Fulcrum Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on developing products for improving the lives of patients with genetically defined diseases in the areas of high unmet medical need in the United States. Its product candidates are losmapimod, a small molecule for the treatment of facioscapulohumeral muscular dystrophy is under phase III clinical trial; and pociredir, a fetal hemoglobin inducer for the treatment of sickle cell disease and beta-thalassemia is under phase I clinical trial. The company is also discovering drug targets for the treatments of rare neuromuscular, muscular, central nervous system, and hematologic disorders, as well as cardiomyopathies and pulmonary diseases. It has collaboration and license agreement with Acceleron Pharma Inc. to identify biological targets to modulate specific pathways associated with a targeted indication within the pulmonary disease space; MyoKardia, Inc. to discover and develop therapies for the treatment of genetic cardiomyopathies; and Sanofi for the development and commercialization of losmapimod, an oral small molecule being investigated for the treatment of facioscapulohumeral muscular dystrophy. Fulcrum Therapeutics, Inc. was Incorporated in 2015 and is headquartered in Cambridge, Massachusetts.

Fulcrum Therapeutics, Inc.

Fulcrum Therapeutics FULC, a clinical-stage company, is expected to report third-quarter 2024 results early next month. The Zacks Consensus Estimate for the to-be-reported quarter’s loss is pinned at 40 cents per share. The company currently does not have any marketed products and does not record any revenues.
The Zacks Consensus Estimate for Fulcrum’s loss per share has narrowed from 46 cents to 28 cents for 2024 over the past 60 days, while that for 2025 has narrowed from $1.51 to $1.14.
FULC Estimate Movement
Image Source: Zacks Investment Research
FULC’s Earnings Surprise History
Fulcrum’s performance has been impeccable over the trailing four quarters. The company beat earnings estimates in each of the last four reported quarters, delivering an average earnings surprise of 393.18%. In the last reported quarter, the company came up with an earnings surprise of 1,550%.
Image Source: Zacks Investment Research
Earnings Whispers
Our proven model does not conclusively predict an earnings beat for Fulcrum this time around. The combination of a positive Earnings ESP and a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold) increases the odds of an earnings beat. That is not the case here, as you will see below. You can uncover the best stocks to buy or sell before they're reported with our Earnings ESP Filter.
Fulcrum has an Earnings ESP of 0.00% and a Zacks Rank #2 at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Stay up-to-date with all quarterly releases:See Zacks Earnings Calendar.
Factors Shaping FULC’s Upcoming Results
In the absence of an approved product, investors can expect updates regarding Fulcrum’s pipeline development on the third-quarter conference call.
During the third quarter, the company faced a major setback when it announced disappointing top-line data from a late-stage study, which evaluated its pipeline candidate, losmapimod, for facioscapulohumeral muscular dystrophy (FSHD), a rare and debilitating disease. Per the data readout, the phase III REACH study of losmapimod for FSHD did not meet its primary endpoint. The study also failed to achieve nominal statistical significance on the secondary endpoints. Following the disappointing REACH study results, Fulcrum decided to stop the further development of losmapimod in FSHD.
Having scraped the FSHD program, Fulcrum has shifted its focus to pociredir, which is currently being developed in an early-stage study for treating patients with sickle cell disease (SCD), an inherited blood disorder.
Pocirediris is an investigational oral small-molecule inhibitor of embryonic ectoderm development and Fulcrum’s only clinical-stage pipeline candidate. It was developed using the company’s proprietary drug discovery technology, FulcrumSeek. FULC is currently evaluating four once-daily dosage strengths of pociredir (2 mg, 6 mg, 12 mg and 20 mg) in separate cohorts in a phase Ib study to treat SCD. Each cohort is expected to enroll approximately 10 patients. Top-line data from this study is expected in 2025.
SCD offers a lucrative market space for Fulcrum despite the presence of approved products. Vertex VRTX and CRISPR Therapeutics CRSP market their one-time gene therapy for SCD and transfusion-dependent beta thalassemia, Casgevy(exa-cel). Notably, Casgevy was approved in multiple geographies in 2023 and early 2024, including the United States and the EU. bluebird bio BLUE also markets its own SCD therapy under the brand name, Lyfgenia (lovo-cel). BLUE’s Lyfgenia has a different mechanism of action than that of VRTX/CRSP’s Casgevy. Several other biotech firms are also currently developing SCD treatments.
FULC’s Price Performance & Attractive Valuation
The stock has plummeted 52% in the year-to-date period compared with the industry’s 3.5% decline. FULC has also underperformed in the sector and the S&P 500 in the same period, as seen in the chart below.
FULC Stock Underperforms the Industry, Sector & the S&P 500
Image Source: Zacks Investment Research
From a valuation standpoint, Fulcrum appears attractive relative to the industry and is trading below its five-year mean. Going by the price/book value ratio, the company’s shares currently trade at 0.74 trailing 12-month book value, lower than 3.9 for the industry and the stock’s five-year mean of 2.25.
FULC Stock Valuation
Image Source: Zacks Investment Research
Investment Thesis
Despite the recent setback, it is not the end of the world for the company as its SCD treatment candidate, pociredir, exhibits significant potential to be the reason for Fulcrum’s turnaround.
In early-stage studies, pociredir demonstrated proof-of-concept by achieving increases in HbF levels, indicating potential patient benefits. The candidate has also been previously observed to be generally well-tolerated in individuals with SCD with up to three months of use and no serious treatment-related adverse events reported.
Pocirediris enjoys the Fast Track designation and Orphan Drug designation in the United States for the treatment of SCD patients. SCD has a significant unmet medical need, and if successfully developed and upon potential approval, pociredir has the potential to boost FULC’s prospects.
Consider Buying FULC Stock
The unsuccessful FSHD study on losmapimod has left Fulcrum’s clinical pipeline without a late-stage candidate and considerably delayed its revenue prospects. However, investors should note that pociredir for SCD, while still in the early stages of development, shows significant promise and has the potential to drive the company’s growth sooner than anticipated.
The SCD market offers strong growth potential due to regulatory incentives and heightened public awareness. Fulcrum’s pociredir has already demonstrated promising efficacy and safety trends in SCD patients. If the upcoming phase Ib study for pociredir yields positive top-line results in 2025, the stock could see significant gains. Consistently improving earnings estimates highlight analysts’ optimistic outlook for sustained growth in the future.
Given these factors, investors are encouraged to look beyond the recent pipeline setback. The current dip in the share price has led to an attractive valuation, presenting a significant opportunity for investors to add the stock to their portfolio.
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Fulcrum Before Q3 Earnings: How Should Investors Play the Stock?

Shares of Fulcrum Therapeutics FULC, a clinical-stage company, have plummeted 58% in the past month compared with the industry’s 2.7% decline. FULC has also underperformed in the sector and the S&P 500 in the past month, as seen in the chart below.
FULC Stock Underperforms the Industry, Sector & the S&P 500
Image Source: Zacks Investment Research
The dip in the stock price was primarily observed after the company faced a major setback in September when it announced disappointing top-line data from a late-stage study, which evaluated its pipeline candidate, losmapimod, for facioscapulohumeral muscular dystrophy (FSHD), a rare and debilitating disease. Currently, there are no treatments approved for the given indication.
Per the data readout, the phase III REACH study for FSHD did not meet its primary endpoint as treatment with losmapimod failed to demonstrate a change from baseline in relative surface area, a measure of reachable workspace, compared with placebo at week 48. The study also failed to achieve nominal statistical significance on the secondary endpoints. Following the disappointing data observed in the REACH study, Fulcrum decided to stop the further development of losmapimod in FSHD.
However, this is not the end of the world for the company as its clinical-stage pipeline has another promising candidate, which is likely to be the reason for FULC’s turnaround. Let’s dig deeper into the factors governing the company’s prospects to understand how to play the stock after the recent price drop.
FULC’s SCD Program Has Significant Potential
Having scraped the FSHD program, Fulcrum has shifted its focus to pociredir, which is currently being developed in an early-stage study for treating patients with sickle cell disease (SCD), an inherited blood disorder.
Pocirediris is an investigational oral small-molecule inhibitor of embryonic ectoderm development (EED). It was developed using Fulcrum’s proprietary drug discovery technology, FulcrumSeek. FULC is currently evaluating four once-daily dosage strengths of pociredir (2 mg, 6 mg, 12 mg and 20 mg) in separate cohorts in a phase Ib study to treat SCD. Each cohort is expected to enroll approximately 10 patients. Top-line data from this study is expected in 2025.
Early data in SCD showed that pociredir successfully demonstrated proof-of-concept by achieving increases in HbF levels, indicating potential patient benefits. Prior to the clinical hold on the phase Ib study, which was in place from February to August 2023, it was observed that the candidate was generally well-tolerated in individuals with SCD, with up to three months of use and no serious treatment-related adverse events reported.
Pocirediris already enjoys the Fast Track designation and Orphan Drug designation in the United States for the treatment of SCD patients. SCD has a significant unmet medical need, and if successfully developed and upon potential approval, pociredir has the potential to boost FULC’s prospects in the days ahead.
Vertex VRTX and CRISPR Therapeutics CRSP market their one-time gene therapy for SCD and transfusion-dependent beta thalassemia, Casgevy(exa-cel). Notably, Casgevy was approved in multiple geographies in 2023 and early 2024, including the United States and the EU. bluebird bio BLUE also markets its own SCD therapy under the brand name, Lyfgenia (lovo-cel). BLUE’s Lyfgenia has a different mechanism of action than that of VRTX/CRSP’s Casgevy. Several other biotech firms are also currently developing SCD treatments.
FULC’s Attractive Valuation, Improving Earnings Estimates
From a valuation standpoint, Fulcrum appears attractive relative to the industry and is trading below its 5-year mean. Going by the price/book value ratio, the company shares currently trade at 0.81 trailing 12-month book value, lower than 3.89 for the industry and the stock’s 5-year mean of 2.25.
FULC Stock Valuation
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for Fulcrum’s loss per share has narrowed from 46 cents to 28 cents for 2024 over the past 60 days, while that for 2025 has narrowed from a loss per share of $1.51 to $1.14.
FULC Estimate Movement
Image Source: Zacks Investment Research
Consider Buying FULC Stock
The unsuccessful FSHD study on losmapimod has left Fulcrum’s clinical pipeline without a late-stage candidate and considerably delayed its revenue prospects. However, investors should note that the company has another developmental candidate, pociredir, in its pipeline. While still in the early stages of development, Fulcrum’s pociredir program for treating SCD shows promise and has the potential to drive company growth sooner than anticipated.
The SCD market offers strong growth potential due to regulatory incentives and heightened public awareness. Fulcrum’s pociredir has already demonstrated promising efficacy and safety trends in SCD patients. If the upcoming phase Ib study for pociredir yields positive top-line results in 2025, the stock could see significant gains. Consistently improving loss estimates highlight analysts’ optimistic outlook for sustained growth in the future.
Given these factors, investors are encouraged to look beyond the recent pipeline setback and consider adding this Zacks Rank #2 (Buy) stock to their portfolio, particularly keeping in mind the significant potential of pociredir for SCD. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report
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Fulcrum Stock Tanks 58% in a Month: Buying Opportunity or Risky Bet?

Gilead Sciences GILD has entered into licensing deals with six pharmaceutical companies to manufacture and supply a cheaper version of its investigational drug, lenacapavir, for HIV prevention, also called pre-exposure prophylaxis (PrEP). These companies will market the low-cost versions of lenacapavir, if approved, in 120 primarily low-and-lower-middle-income countries.
The companies chosen to manufacture and supply lenacapavir to 120 countries are Dr. Reddy’s Laboratories, Emcure, Eva Pharma, Ferozsons Laboratories, Hetero, and Mylan (a Viatris subsidiary).
While lenacapavir is not yet approved for use anywhere and its safety and efficacy are still unproven, Gilead believes the drug has the potential to be transformative for HIV prevention, where there is a significant unmet need. Currently, no cure exists for HIV or AIDS.
Earlier this year, Gilead reported that two pivotal late-stage studies, PURPOSE 1 and PURPOSE 2, evaluating the safety and efficacy of lenacapavir to reduce the chance of getting HIV, achieved their primary efficacy goals. Per the data readout, it was observed that the candidate, administered twice a year, demonstrated superior efficacy over the once-daily oral dose of Truvada and background HIV incidence.
Using data from these studies, Gilead plans to submit global regulatory filings by the end of 2024. Year to date, shares of GILD have gained 4.6% against the industry’s 1.5% decline.
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GILD’s Voluntary Licensing Agreement for Lenacapavir
Gilead plans to support low-cost access in high-incidence, resource-limited countries through a two-pronged approach – establishing a strong, royalty-free, voluntary licensing program and providing lenacapavir at no profit until generic manufacturers can meet demand. The agreements cover lenacapavir for both HIV prevention (pending approval) and for treatment in heavily treatment-experienced adults with multi-drug-resistant HIV.
Gilead selected these partners based on strict criteria due to the complexities of producing lenacapavir. All six companies have previously worked with Gilead to produce high-quality generics for HIV and other infectious diseases, and they are experienced in making sterile injectable medicines. Gilead also considered advice from global health advocates, opting for manufacturers from various countries and continents.
On the other hand, the licensees will work to build manufacturing capacity for lenacapavir rapidly. However, this will take time.
Therefore, until generic versions are available, Gilead will supply lenacapavir directly and is focusing on registering the candidate in 18 countries that account for about 70% of the HIV burden in the licensed regions. These countries, chosen in consultation with external partners, include Botswana, Eswatini, Ethiopia, Kenya, Lesotho, Malawi, Mozambique, Namibia, Nigeria, the Philippines, Rwanda, South Africa, Tanzania, Thailand, Uganda, Vietnam, Zambia, and Zimbabwe.
In the past, Gilead’s partnerships with generic manufacturers have enabled millions to access affordable treatments for HIV, viral hepatitis and COVID-19. Over 30 million treatments have been distributed in low-and-middle-income countries through these collaborations.
Gilead Sciences, Inc. Price and Consensus
Gilead Sciences, Inc. price-consensus-chart | Gilead Sciences, Inc. Quote
GILD’s Zacks Rank & Stocks to Consider
Gilead currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 4.3%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $1.91 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have soared 43%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from 46 cents to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.67 to $1.14. Year to date, shares of FULC have plunged 42.7%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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GILD Grants Right for HIV PrEP Candidate to Six Generic Companies

Shares of Prime Medicine, Inc. PRME were up 11.85% after the company announced a strategic research collaboration and license agreement with biotech giant Bristol Myers Squibb BMY.
The collaboration is aimed at developing reagents for the next generation of ex vivo T-cell therapies.
Year to date, PRME’s shares have lost 56.3% compared with the industry’s decline of 1.2%.
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Terms of PRME’s Deal With BMY
Prime Medicine is deploying its proprietary gene editing technology, Prime Editing platform, to develop a new class of differentiated one-time curative genetic therapies.
Per the terms of the deal, Bristol Myers will be responsible for the development, manufacturing and commercialization of the next-generation cell therapies, with support from Prime Medicine in gene editing strategy and reagent development.
In exchange, PRME will receive an upfront payment of $55 million and an equity investment worth $55 million from BMY.
Prime Medicine is also eligible to receive more than $3.5 billion in milestones, including up to $1.4 billion in development milestones and more than $2.1 billion in commercialization milestones, along with royalties on net sales.
The equity investment from BMY impressed investors.
The deal with BMY will allow PRME to apply its Prime Editing technology beyond rare genetic diseases.
PRME’s Strategic Pipeline Progress
Prime Medicine also announced that it is prioritizing development in core areas of focus. The company will focus on the development of two programs, PM359 and another candidate, for the treatment of chronic granulomatous disease (CGD).
In April 2024, the FDA cleared an investigational new drug (IND) application for PM359. PRME has initiated a phase I/II clinical trial to assess the safety, biological activity and preliminary efficacy of PM359 in adult and pediatric patients. It expects initial clinical data from the study in 2025.
The company’s other program is an ex vivo hematopoietic stem cell product for the treatment of X-linked CGD.
Per PRME, these two programs have the potential to address the vast majority of people living with CGD.
Prime Medicine is also focused on advancing its Wilson’s Disease program, which targets prevalent mutations in the ATP7B gene. The company expects to initiate IND-enabling activities for this program in the fourth quarter of 2024, and intends to file an IND and/or clinical trial application in the first half of 2026.
As a result of this strategic pipeline prioritization, Prime Medicine will streamline its operating expenses and capital expenditures.
Prime Medicine expects its cash runway to fund operations into the first half of 2026 after receiving an upfront payment of $110 million from BMY.
PRME’s Zacks Rank and Stocks to Consider
PRME currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $1.91 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 42.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters and missed the same in one, the average surprise being 45.95%.
In the past 90 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14.
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PRME Stock Rises 11.8% on Collaboration With Bristol Myers

AbbVie ABBV announced that it has submitted a biologics license application (BLA) to the FDA seeking accelerated approval for its investigational antibody-drug conjugate (ADC) telisotuzumab vedotin (Teliso-V) for previously treated EGFR wild type non-squamous non-small cell lung (NSCLC) cancer in adult patients with c-Met overexpression.
Currently, there are no FDA-approved therapies for treating c-Met overexpressing NSCLC.
If approved, Teliso-V will become the first-in-class therapy for the given indication.
Year to date, shares of AbbVie have rallied 25.7% compared with the industry‘s 20.2% rise.
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BLA Based on ABBV's LUMINOSITY Study
The above BLA, which seeks an accelerated nod for Teliso-V in c-Met overexpressing NSCLC, was based on data from the phase II LUMINOSITY study.
The company announced encouraging top-line data from the phase II LUMINOSITY study last November.
Data from the study showed that study participants treated with Teliso V achieved an overall response rate (ORR) of 35% across c-Met high patients and 23% across c-Met intermediate patients.
Per management, c-Met overexpression is found in 25% of advanced EGFR wild-type NSCLC patients and is also associated with a poor prognosis for these patients.
More Updates on ABBV's c-Met ADC – Teliso-V
Teliso-V has been developed by AbbVie to target the c-Met protein, which is overexpressed in many solid tumors, including NSCLC.
The company is also evaluating Teliso-V as a monotherapy in the phase III confirmatory study called TeliMET NSCLC-01 in patients with previously treated c-Met overexpressing EGFR wild-type NSCLC. Enrollment in the study is currently ongoing.
Teliso-V is a key part of AbbVie’s oncology pipeline. The company has another promising cancer candidate, ABBV-383, a BCMA CD3 bispecific, which is being evaluated in a phase III study for treating relapsed/refractory multiple myeloma. Several regulatory updates and key data readouts are expected in the next 12 months.
ABBV's Zacks Rank & Stocks to Consider
AbbVie currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 6.6%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $1.91 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 42.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 44.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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AbbVie Seeks Approval for Lung Cancer Candidate Teliso-V

Sage Therapeutics, Inc. SAGE announced that partner Biogen BIIB has terminated its rights related to the investigational neurology candidate, SAGE-324. A phase II study on SAGE-324 for treating essential tremor (ET) failed to meet the primary endpoint in July.
The termination will be effective from Feb. 17, 2025.
Following the termination of the deal by BIIB, Sage Therapeutics will obtain full ownership and rights of SAGE-324. The company plans to study SAGE-324 for other indications, if any.
Year to date, shares of Sage Therapeutics have plunged 66.9% compared with the industry’s decrease of 1.9%.
Image Source: Zacks Investment Research
SAGE’s Licensing Agreement With BIIB
In July, Sage Therapeutics and Biogen announced top-line data from the phase II KINETIC 2 study, which evaluated SAGE-324 as a potential treatment for ET. The study failed to demonstrate a statistically significant dose-response relationship on the primary endpoint in participants with ET.
Based on the disappointing data, SAGE and BIIB decided to stop further clinical development of SAGE-324 in ET.
SAGE currently markets the depression drug Zurzuvae (zuranolone) in partnership with Biogen.
Zurzuvae, the first and only oral treatment indicated for adults with postpartum depression (PPD), was approved by the FDA in August 2023 and commercially launched in December.
Sage Therapeutics and Biogen, equally share profits and losses for the commercialization of Zurzuvae in the United States. In ex-U.S. markets, Biogen records product sales (excluding Japan, Taiwan and South Korea) and pays royalties to Sage Therapeutics.
Sage Therapeutics and BIIB are focused on establishing Zurzuvae as a first-line therapy and the standard of care for women with PPD.
The FDA issued a complete response letter (CRL) for the new drug application (NDA) for zuranolone for treating adults with major depressive disorder in August 2023. Per the FDA, the data supporting the NDA filing did not provide substantial evidence of effectiveness to support a potential approval. It recommended conducting additional clinical studies.
The company is evaluating the necessary steps to address this CRL.
SAGE’s Zacks Rank & Stocks to Consider
Sage Therapeutics currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $2.09 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 43.8%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 40.8%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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Biogen Inc. (BIIB) : Free Stock Analysis Report
Sage Therapeutics, Inc. (SAGE) : Free Stock Analysis Report
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SAGE, BIIB End Collaboration for Neurology Candidate SAGE-324

Merck MRK announced data from the phase III KEYFORM-007 study, which evaluated a fixed-dose combination of its anti-LAG-3 antibody, favezelimab and its blockbuster anti-PD-1 therapy, Keytruda in pre-treated patients with PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC).
The study failed to meet the primary endpoint of overall survival (OS).
Year to date, shares of Merck have gained 5.2% compared with the industry’s rise of 22.8%.
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What Did MRK's KEYFORM-007 Study Show?
The randomized phase III KEYFORM-007 study evaluated the fixed-dose combination of favezelimab and Keytruda compared to standard of care, regorafenib for the treatment of patients with PD-L1 positive MSS mCRC who were previously treated with standard therapies.
At the final pre-specified analysis, treatment with favezelimab + Keytruda failed to demonstrate an improvement in OS versus standard of care – regorafenib in the given patient population.
The safety profile of favezelimab + Keytruda was similar to that of previously reported studies.
Full evaluation of the data from the KEYFORM-007 study is currently ongoing and the company plans to share the same with the scientific community later.
Keytruda is currently approved for treating patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer in the United States as determined by an FDA-approved test. However, the drug is not currently approved for the treatment of MSS mCRC.
The fixed-dose combination of favezelimab plus Keytruda is also being evaluated for certain hematologic malignancies and other solid tumor types. The phase III KEYFORM-008 study is evaluating the fixed-dose combination of favezelimab + Keytruda for treating patients with relapsed or refractory classical Hodgkin lymphoma whose disease has progressed following prior anti-PD-1 therapy.
Keytruda Gets Japan Nod for Certain Lung & Urothelial Cancers
In a separate press release, Merck announced that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Keytruda for three new indications in lung and urothelial cancers.
The MHLW approved Keytruda in combination with chemotherapy as a neoadjuvant treatment, then continued as monotherapy as an adjuvant treatment in non-small cell lung carcinoma (NSCLC).
The Japanese regulatory body also approved Keytruda as a monotherapy for treating radically unresectable urothelial carcinoma in patients who are not eligible for any platinum-containing chemotherapy.
The MHLW also approved Keytruda in combination with Pfizer’s PFE antibody-drug conjugate Padcev (enfortumab vedotin-ejfv) as a first-line treatment of patients with radically unresectable urothelial carcinoma.
The acquisition of Seagen in December 2023 added four antibody-drug conjugates or ADCs — Adcetris, Padcev, Tukysa and Tivdak to PFE’s portfolio of cancer drugs.
Pfizer is particularly witnessing strong demand for Padcev.
Merck's Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are ANI Pharmaceuticals, Inc. ANIP and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have increased 3.9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 31.32%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 48.6%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
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Pfizer Inc. (PFE) : Free Stock Analysis Report
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Fulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report
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MRK's Keytruda Combo Fails in Phase III Colorectal Cancer Study

Apellis Pharmaceuticals APLS announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has confirmed its June 2024 negative opinion on the regulatory filing for intravitreal pegcetacoplan to treat geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Shares of the company lost 11.5% on Friday in response.
Management expressed deep disappointment in the outcome, stating that millions of GA patients in the EU remain without treatment for this irreversible form of blindness. Apellis further reported that the CHMP opinion was issued despite broad support for pegcetacoplan from the European retina community and several dissenting votes from CHMP members who had advocated for a path to approval.
Prior Regulatory Updates for APLS’ Pegcetacoplan
We remind investors that the CHMP had first voted against the marketing authorization application (MAA) for Syfovre to treat GA in January 2024, following which Apellis demanded a re-examination of the same with the EMA. However, in March 2024, the Court of Justice of the European Union (CJEU) issued a judgment that ruled on the organization of EMA’s expert groups, posing implications for the EMA's policy for handling competing interests of experts.
Based on the CJEU’s judgment, the EMA had reset the review of the Syfovre MAA for the GA indication to the last phase of the initial assessment (day 180) in April 2024. Apellis had clarified that the decision to reset the Syfovre MAA review was strictly procedural in response to the CJEU judgment and did not imply any shortcoming in the submission package for the drug, which was intended to support the approval in the EU.
Following the CJEU’s judgment, in June 2024, the CHMP issued a negative opinion for the second time on the MAA for intravitreal pegcetacoplan to treat GA in the EU.
Year to date, shares of APLS have plunged 45.7% against the industry’s 0.5% growth.
Image Source: Zacks Investment Research
APLS’ Portfolio of Marketed Drugs
Please note that pegcetacoplan injection is currently approved in the United States under the brand name Syfovre for treating GA secondary to AMD.
Syfovre was approved by the FDA in February 2023 as the first and only treatment for GA secondary to AMD in the United States. It has the potential to be a best-in-class treatment for patients with GA, a disease that is the leading cause of blindness, affecting more than one million people in the United States and five million people worldwide.
The drug has witnessed robust initial uptake since its commercial launch in March 2023. Syfovre recorded sales of $292.1 million in the first half of 2024, which increased 241% year over year, owing to continued strong demand, thereby driving revenues for the company. As of June 30, 2024, the total number of drug doses delivered since launch was 330,000.
Marketing authorization seeking applications for intravitreal pegcetacoplan for the treatment of GA is currently under review in several other countries apart from the EU, with decisions expected in the current year. Potential approval of the drug in additional geographies will further boost the top line.
Apellis also currently markets pegcetacoplan under the brand name Empaveli/Aspaveli in the United States and EU as a monotherapy treatment for adult patients suffering from paroxysmal nocturnal hemoglobinuria. The drug is also approved in several other geographies for the same indication.
Apellis Pharmaceuticals, Inc. Price and Consensus
Apellis Pharmaceuticals, Inc. price-consensus-chart | Apellis Pharmaceuticals, Inc. Quote
Zacks Rank & Stocks to Consider
Apellis currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Illumina, Inc. ILMN, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 EPS have moved up from $1.84 to $3.63. The consensus estimate for 2025 earnings has improved from $3.22 to $4.43. Year to date, shares of ILMN have lost 5.8%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. Year to date, shares of KRYS have jumped 48.5%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 50.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
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Illumina, Inc. (ILMN) : Free Stock Analysis Report
Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report
Apellis Pharmaceuticals, Inc. (APLS) : Free Stock Analysis Report
Fulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Apellis Stock Down as Eye Drug Faces Third CHMP Rejection in the EU

Vanda Pharmaceuticals Inc. VNDA announced that the FDA issued a complete response letter (CRL) to its new drug application (NDA) seeking approval for its pipeline candidate, tradipitant for the treatment of symptoms in gastroparesis.
Shares of the company were down 6.1% on Sept. 19 following the announcement of the news.
Marked by delayed gastric emptying, gastroparesis is a serious condition that slows down the stomach's ability to empty its contents. The FDA has not approved any effective medicine for treating gastroparesis in more than 40 years.
Year to date, shares of Vanda have increased 10.2% compared with the industry’s rise of 0.4%.
Image Source: Zacks Investment Research
More on FDA's CRL for VNDA's Tradipitant
Per the CRL, the FDA called for Vanda to conduct additional studies on tradipitant with a design that was inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding of the disease.
Also, per management, the FDA delayed its decision by more than 185 days and failed to meet the requirements specified by the Food Drug and Cosmetic Act (FDCA).
Notably, the FDCA requires that the FDA review an NDA and provide either an approval or a possible hearing within 180 days of the filing. The FDA failed to do either.
Per the company, it had time and again asked the FDA to hold an advisory committee meeting to discuss the NDA for tradipitant while the regulatory body declined.
Several patients treated with tradipitant have now filed a Citizen Petition pleading with the regulatory body to approve tradipitant for the treatment of gastroparesis.
VNDA's Development Plans for Tradipitant
Despite the FDA declining to approve tradipitant for treating symptoms in gastroparesis, the company will continue to pursue the marketing approval for tradipitant in the given indication.
Apart from gastroparesis, VNDA is also developing tradipitant for preventing vomiting induced by motion sickness.
In May 2024, the company announced positive data from a second phase III study that investigated tradipitant for preventing vomiting induced by motion sickness.
Vanda plans to submit an NDA for tradipitant to the FDA for the treatment of motion sickness later in 2024.
Zacks Rank & Stocks to Consider
Vanda currently carries a Zacks Rank #4 (Sell).
Some better-ranked stocks in the biotech sector are Illumina, Inc. ILMN, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 earnings per share have moved up from $1.84 to $3.63. Earnings per share estimates for 2025 have improved from $3.22 to $4.43. Year to date, shares of ILMN have lost 3.5%.
ILMN’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 earnings per share have increased from $2.09 to $2.38. Earnings per share estimates for 2025 have improved from $4.33 to $7.31. Year to date, shares of KRYS have risen 48.7%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, with the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.33 to 28 cents. Loss per share estimates for 2025 have narrowed from $1.71 to $1.14. Year to date, shares of FULC have plunged 48.9%.
FULC’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 393.18%.
5 Stocks Set to Double
Each was handpicked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2024. While not all picks can be winners, previous recommendations have soared +143.0%, +175.9%, +498.3% and +673.0%.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Today, See These 5 Potential Home Runs >>
Want the latest recommendations from Zacks Investment Research? Today, you can download 5 Stocks Set to Double. Click to get this free report
Illumina, Inc. (ILMN) : Free Stock Analysis Report
Vanda Pharmaceuticals Inc. (VNDA) : Free Stock Analysis Report
Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report
Fulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report
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VNDA Stock Down as FDA Rejects NDA for Tradipitant in Gastroparesis

Shares of Zoetis ZTS have risen 15.4% in the past three months compared with the industry’s 9.3% growth. The stock has also outperformed the sector as well as the S&P 500 as seen in the chart below. The stock is also trading above both its 50 and 200-day moving averages from early August.
ZTS Stock Outperforms Industry, Sector & S&P 500
Image Source: Zacks Investment Research
Zoetis is a major player in the animal health market. The company operates in eight major product categories: vaccines, anti-infectives, parasiticides, dermatology, other pharmaceutical products, pain and sedation, medicated feed additives and animal health diagnostics.
Zoetis’ diversified product portfolio caters to eight core species, namely, cattle, swine, poultry, fish and sheep (collectively, livestock) and dogs, cats and horses (collectively, companion animals).
Let’s delve deeper to discuss four reasons why adding Zoetis stock to your portfolio may prove beneficial in 2024.
ZTS’ New Products Deliver Strong Performance
Zoetis has built a very strong companion animal portfolio over the last several years based on its internal innovation, which contributes significantly to the top line. Key dermatology products (Apoquel and Cytopoint), new products (such as Simparica and Stronghold Plus) and increased medicalization rates in key international markets are propelling further growth. Zoetis has also received the FDA’s approval for ProHeart 12 (moxidectin), which is the industry’s only once-yearly injection to prevent heartworm disease in dogs aged 12 months or older.
Last year, the regulatory body approved Apoquel Chewable tablets in the United States for controlling pruritus related to allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Zoetis’ Apoquel Chewable is an easier-to-use formulation that has enhanced medication compliance and, therefore, improved outcomes for dogs. Hence, the demand is strong.
The approval of Simparica Trio in Europe and the United States has strengthened the company’s market-leading parasiticide portfolio for companion animals. The uptake of the product has been strong. ZTS also continues to bolster its vaccine portfolio for livestock.
Zoetis received approval for Rimadyl (carprofen) for dogs in China, which is one of the fastest-growing companion animal markets in the world. It is indicated for relief from pain and inflammation associated with osteoarthritis (chewables) and control of postoperative pain related to soft tissue and orthopedic surgeries (injectables).
The uptake of Librela and Solensia, the company’s new monoclonal antibody therapies for osteoarthritis pain in dogs and cats, is also positive and expected to continue to boost growth in upcoming quarters. Approval of other innovative products in the future, along with continued uptake of its existing products, should further boost sales in the quarters ahead.
ZTS Drives Growth Through Strategic Acquisitions
Zoetis has also been expanding its business through acquisitions. Such expansion initiatives bode well for the company, strengthening its position in the animal healthcare market.
During the third quarter of 2023, the company acquired two privately held research and development stage animal health biopharmaceutical companies, PetMedix Ltd. and adivo GmbH. PetMedix develops antibody-based therapeutics for companion animals. This acquisition is expected to strengthen Zoetis’ companion animal products portfolio.
In early 2024, Zoetis expanded the capabilities of its multi-application diagnostics platform, Vetscan Imagyst, to include AI Urine Sediment analysis. This new feature facilitates accurate, in-clinic sediment analysis of fresh urine, allowing veterinarians to make treatment decisions quickly.
Vetscan Imagyst is the first and only AI-driven diagnostics technology to provide five applications in a single platform, offering analysis at the point of care. The AI-driven nature of this additional feature offers veterinarians fast, consistent and accurate results to devise individualized treatment plans that benefit both pets and pet owners.
This new additional feature broadens the already existing wide range of high-value, in-clinic diagnostics offered by Vetscan Imagyst, thus facilitating better treatment.
ZTS’ Zacks Rank, Premium Valuation & Rising Estimates
Zoetis currently carries a Zacks Rank #2 (Buy).
The stock is currently trading at a premium to the industry, as seen in the chart below. However, it might be prudent to add ZTS to your portfolio despite the premium valuation, as the company's strong fundamentals will generate lucrative returns in the future.
Image Source: Zacks Investment Research
In the past 60 days, the Zacks Consensus Estimate for Zoetis’ 2024 earnings per share (EPS) has increased from $5.76 to $5.83. During the same time frame, the consensus estimate for ZTS’ 2025 EPS has increased from $6.32 to $6.42.
Image Source: Zacks Investment Research
Consistently rising earnings estimates highlight analysts’ optimistic outlook for further growth.
ZTS Boosts Shareholder Value With Increased Dividends
Zoetis has been consistently increasing dividends for shareholders, which is another lucrative reason to add the stock to your portfolio. ZTS’ board declared a dividend of $0.432 per share for the third quarter of 2024, representing an increase of 15% from the quarterly dividend rate paid in 2023.
Other Stocks to Consider
Some other top-ranked stocks in the biotech sector are Illumina, Inc. ILMN, Krystal Biotech, Inc. KRYS and Fulcrum Therapeutics, Inc. FULC, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Illumina’s 2024 EPS have moved up from $1.84 to $3.62. The consensus estimate for 2025 earnings has improved from $3.22 to $4.43. In the past three months, shares of ILMN have gained 20.5%.
ILMN’s earnings beat estimates in each of the trailing four quarters, the average surprise being 463.46%.
In the past 60 days, estimates for Krystal Biotech’s 2024 EPS have increased from $2.09 to $2.38. The consensus estimate for 2025 earnings has improved from $4.33 to $7.31. In the past three months, shares of KRYS have jumped 9.4%.
KRYS’ earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 45.95%.
In the past 60 days, estimates for Fulcrum Therapeutics’ 2024 loss per share have narrowed from $1.24 to 33 cents. The consensus estimate for 2025 loss per share has narrowed from $1.71 to $1.14. In the past three months, shares of FULC have plunged 46.2%.
FULC’s earnings beat estimates in each of the trailing four quarters, the average surprise being 393.18%.
Zacks Names #1 Semiconductor Stock
It's only 1/9,000th the size of NVIDIA which skyrocketed more than +800% since we recommended it. NVIDIA is still strong, but our new top chip stock has much more room to boom.
With strong earnings growth and an expanding customer base, it's positioned to feed the rampant demand for Artificial Intelligence, Machine Learning, and Internet of Things. Global semiconductor manufacturing is projected to explode from $452 billion in 2021 to $803 billion by 2028.
See This Stock Now for Free >>
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Illumina, Inc. (ILMN) : Free Stock Analysis Report
Zoetis Inc. (ZTS) : Free Stock Analysis Report
Krystal Biotech, Inc. (KRYS) : Free Stock Analysis Report
Fulcrum Therapeutics, Inc. (FULC) : Free Stock Analysis Report
To read this article on Zacks.com click here.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Fulcrum Therapeutics, Inc.

Price history and volume

Shares 360

Investment risk — low

Investment potential — low

Security parameters