RAPT Therapeutics, Inc., a clinical-stage immunology-based biopharmaceutical company, focuses on discovery, development, and commercialization of oral small molecule therapies for patients with unmet needs in oncology and inflammatory diseases in the United States. The company's lead inflammation drug candidate is zelnecirnon (RPT193), a C-C motif chemokine receptor 4 (CCR4) antagonist that selectively inhibit the migration of type 2 T helper cells into inflamed tissues. Its lead oncology drug candidate is tivumecirnon (FLX475), an oral small molecule CCR4 antagonist that is in the Phase 1/2 clinical trial to investigate as a monotherapy and in combination with pembrolizumab in patients with advanced cancer. The company was formerly known as FLX Bio, Inc. and changed its name to RAPT Therapeutics, Inc. in May 2019. RAPT Therapeutics, Inc. was incorporated in 2015 and is headquartered in South San Francisco, California. RAPT Therapeutics, Inc. is a subsidiary of Bristol-Myers Squibb Company

RAPT Therapeutics, Inc.

Here are five stocks added to the Zacks Rank #1 (Strong Buy) List today:
Telefónica, S.A. TEF: This telecommunications services company has seen the Zacks Consensus Estimate for its current year earnings increasing 9.1% over the last 60 days.
Atlantica Sustainable Infrastructure plc AY: This renewable energy company has seen the Zacks Consensus Estimate for its current year earnings increasing 12.2% over the last 60 days.
Allot Ltd. ALLT: This network security provider has seen the Zacks Consensus Estimate for its current year earnings increasing 75% over the last 60 days.
Theravance Biopharma, Inc. TBPH: This biopharmaceutical company has seen the Zacks Consensus Estimate for its next year earnings increasing 115.4% over the last 60 days.
Virco Mfg. Corporation VIRC: This furniture company has seen the Zacks Consensus Estimate for its current year earnings increasing 16.3% over the last 60 days.
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks 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.

New Strong Buy Stocks for July 15th

(RTTNews) - RAPT Therapeutics (RAPT), and Shanghai Jemincare Pharmaceutical Co., a subsidiary of Jiangxi Jemincare Group, have entered into an exclusive license agreement for JYB1904, or RPT904, a clinical-stage, half-life extended anti-immunoglobulin E monoclonal antibody. RAPT is granted worldwide rights excluding mainland China, Hong Kong, Macau and Taiwan to develop and commercialize RPT904. Jemincare received a $35 million upfront license fee, up to $672.5 million in additional payments upon the achievement of various regulatory and commercial milestones, and royalties on future sales of RPT904 outside the Jemincare Territory.
RPT904 is being developed to offer patients a potentially improved therapeutic option compared to omalizumab, an anti-IgE monoclonal antibody approved for several allergic disorders, including asthma, chronic spontaneous urticaria, chronic rhinosinusitis with nasal polyps and, most recently, food allergy.
RAPT plans to pursue development of RPT904 initially in food allergy. Jemincare is conducting Phase 2 clinical trials of JYB1904 in China in asthma and chronic spontaneous urticaria.
Shares of RAPT are up 62% in pre-market trade on Monday.
For More Such Health News, visit rttnews.com.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Why RAPT Therapeutics Is Rising In Pre-market?

Theravance Biopharma’s TBPH lead pipeline candidate is ampreloxetine, which is being developed for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA).
Theravance has collaborated with Viatris VTRS for the commercialization of Yupelri, as a once-daily, nebulized treatment of chronic obstructive pulmonary disease (COPD) in the United States.
Here are some reasons why investors should consider betting on Theravance stock.
Good Rank and Rising Estimates: Theravance currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 30 days, estimates for Theravance’s 2024 earnings per share have improved from breakeven to 6 cents. During the same period, earnings per share estimates for 2025 have moved up from 80 cents to 85 cents.
Prioritizing Resource Allocation Toward Ampreloxetine: Theravance is prioritizing the development of ampreloxetine, a norepinephrine reuptake inhibitor, for the treatment of symptomatic nOH in patients with MSA. The FDA has granted Orphan Drug designation to ampreloxetine for the treatment of symptomatic nOH in patients with MSA.
The phase III CYPRESS study is evaluating ampreloxetine for treating nOH in patients with MSA. Patient enrollment in the study is expected to be completed by the second half of 2024, with top-line data from the same expected in 2025. TBPH plans to submit regulatory filings for ampreloxetine if data from the CYPRESS study is found to be positive.
Shares of Theravance have declined 25.3% year to date compared with the industry’s decline of 7.9%.
Image Source: Zacks Investment Research
Yupelri Holds Significant Potential: Yupelri is the first once-daily nebulized, long-acting muscarinic antagonist (LAMA) option for COPD patients. Yupelri provides COPD patients with access to a nebulized LAMA therapy, offering a consistent 24-hour lung function improvement with the convenience of once-daily dosing delivered through any standard jet nebulizer.
Viatris and Theravance share U.S. profits and losses received in connection with the commercialization of Yupelri. While Viatris gets 65% of the profits, Theravance receives the remaining 35%. Viatris’ collaboration revenues include Theravance’s 35% share of net sales of Yupelri, as well as its proportionate amount of the total shared costs incurred by the two companies.
Viatris recognizes product sales from Yupelri and also owns a stake in Theravance.Yupelri has been witnessing strong sales uptake so far and the momentum is likely to continue for the rest of 2024.
Restructuring Initiatives Saving Costs: In 2021, Theravance implemented a major cost-reduction program and undertook various strategic actions to prioritize its pipeline development aimed at maximizing shareholder value. The decision was taken following the failure of its two non-respiratory disease-related pipeline candidates in two different clinical studies. The restructuring was completed in the third quarter of 2022, resulting in significant cost savings for the company.
As a result of the portfolio prioritization and streamlining of its operations, the company reduced its workforce by almost 17% in March 2023, leading to substantial cost savings.
Other Stocks to Consider
Some other stocks to consider in the healthcare sector are Aligos Therapeutics, Inc. ALGS and RAPT Therapeutics, Inc. RAPT, each carrying a Zacks Rank #2 at present.
In the past 60 days, estimates for Aligos Therapeutics’ 2024 loss per share have narrowed from 84 cents to 73 cents, while loss per share estimates for 2025 have narrowed from 82 cents to 71 cents. Year to date, shares of ALGS have declined 39.3%.
ALGS’s earnings beat estimates in three of the trailing four quarters and missed on the other occasion, the average surprise being 7.83%.
In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $3.19 to $2.93. Loss per share estimates for 2025 have narrowed from $2.40 to $2.05. Year to date, shares of RAPT have plunged 87.6%.
RAPT’s earnings beat estimates in two of the trailing four quarters while missing on the remaining two occasions, the average surprise being 3.19%.
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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.

Here's Why You May Invest in Theravance (TBPH) Stock Now

For Immediate Release
Chicago, IL – February 23, 2024 – Zacks.com announces the list of stocks featured in the Analyst Blog. Every day the Zacks Equity Research analysts discuss the latest news and events impacting stocks and the financial markets. Stocks recently featured in the blog include: Moderna MRNA, RAPT Therapeutics, Inc. RAPT, Iovance Biotherapeutics, Inc. IOVA, Sarepta Therapeutics SRPT and Regeneron Pharmaceuticals, Inc. REGN.
Here are highlights from Thursday’s Analyst Blog:
Biotech Stock Roundup: Q4 Earnings, Approvals & More
Earnings updates continue to be in focus in the biotech sector as we move through the last leg of the earnings cycle. Concurrently, pipeline and regulatory updates continue to be in the spotlight as well.
Recap of the Week’s Most Important Stories:
Moderna’s Q4 Earnings: Moderna reported earnings of 55 cents per share in the fourth quarter of 2023, which beat the Zacks Consensus Estimate of a loss of 78 cents per share. Revenues of $2.8 billion beat the Zacks Consensus Estimate of $2.5 billion. Revenues primarily comprise COVID-19 Vaccine Spikevax sales. Moderna reaffirmed its product sales guidance of approximately $4 billion for 2024.
Moderna continues to expect initial regulatory approvals for its RSV vaccine (mRNA-1345), starting in the first half of 2024.
RAPT Crashes on Study Failure: RAPT Therapeutics, Inc. announced that the FDA notified that a clinical hold has been placed on the company’s phase IIb trial of zelnecirnon (RPT193) in atopic dermatitis and phase IIa trial in asthma. Shares of this clinical-stage, immunology-based biopharmaceutical company crashed on the news. While the FDA informed RAPT verbally, the latter is yet to receive a formal clinical hold letter from the agency.
The hold was placed due to a serious adverse event of liver failure in one patient in the atopic dermatitis trial, the cause of which is currently unknown but has been characterized as potentially related to zelnecirnon. Dosing of zelnecirnon has been halted in both clinical trials. Enrollment of new trial participants has also been paused. The clinical hold does not apply to RAPT’s ongoing trial of tivumecirnon (FLX475) in oncology.
Per the company, approximately 350 patients have been enrolled across three clinical studies evaluating zelnecirnon — the two phase II trials and an earlier phase Ia/Ib study. No evidence of liver toxicity has been observed with any other trial participant. Additionally, no evidence of liver toxicity was observed in nonclinical studies.
IOVA Surges on Drug Approval: Shares of Iovance Biotherapeutics, Inc. surged after the company obtained FDA-granted accelerated approval to lifileucel suspension for intravenous infusion under the brand name Amtagvi.
Lifileucel is a tumor-derived autologous T cell immunotherapy, indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor.
The FDA’s accelerated approval was based on safety and efficacy data from the phase II C-144-01 study, which evaluated Amtagvi in patients with advanced melanoma, previously treated with anti-PD-1 therapy and targeted therapy. Treatment with Amtagvi led to deep and durable responses in the given patient population. The accelerated nod from the regulatory body was based on the overall response rate and duration of response. Iovance is evaluating Amtagvi in frontline advanced melanoma in the phase III confirmatory study, TILVANCE-301, as well as additional solid tumor types.
IOVA currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Sarepta Up on Regulatory Update: Sarepta Therapeutics’ shares rose after the FDA accepted its efficacy supplement to the biologics license application (BLA), seeking to expand the treatment label for its Duchenne muscular dystrophy (DMD) drug, Elevidys. The FDA has assigned the Priority Review status to the company’s Elevidys filing with a review goal date of Jun 21, 2024.
Elevidys was initially approved by the FDA in June 2023 under the accelerated pathway to treat ambulatory pediatric patients aged between four and five years with DMD.
The efficacy supplement seeks to expand the labeled indication for Elevidys to treat all DMD patients, irrespective of age and ambulation status. Subject to approval, it will also convert the Elevidys accelerated approval to a traditional approval.
Sarepta also reported that the regulatory body has confirmed that it will not hold any advisory committee meeting to discuss the efficacy supplement to the Elevidys BLA.
Regeneron’s Myeloma Drug Gets Priority Review: Regeneron Pharmaceuticals, Inc. announced that its biologics license application (BLA), seeking approval of linvoseltamab for the treatment of adult patients with relapsed/refractory (R/R) multiple myeloma (MM) that has progressed after at least three prior therapies has been accepted by the FDA. The regulatory body has granted Priority Review to the same with a target action date of Aug 22, 2024.
The BLA is supported by data from a phase I/II pivotal trial (LINKER-MM1) investigating linvoseltamab in R/R MM.
The linvoseltamab clinical development program includes a phase III confirmatory trial in patients with R/R MM (LINKER-MM3) that is currently enrolling. Additional trials in earlier lines of therapy and stages of disease are planned or underway, including a phase I/II study in the first-line setting, a phase II trial in high-risk smoldering MM and a phase II trial in monoclonal gammopathy of undetermined significance. A phase I study of linvoseltamab, in combination with a Regeneron CD38xCD28 costimulatory bispecific in MM, is also planned.
Performance
The Nasdaq Biotechnology Index has gained 0.73% in the past four trading sessions. Among the biotech giants, Incyte has gained 4.21% during the period. Over the past six months, shares of GSK have surged 22.6%. (See the last biotech stock roundup here: Biotech Stock Roundup: BIIB’s Q4 Results, CBAY Up on GILD’s Acquisition & Other Updates)
What's Next in Biotech?
Stay tuned for more earnings and pipeline updates.
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The Zacks Analyst Blog Highlights Moderna, RAPT Therapeutics, Iovance, Sarepta Therapeutics and Regeneron

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(RTTNews) - RAPT Therapeutics, Inc. (RAPT), Tuesday announced that the U.S. Food and Drug Administration or FDA had verbally put on hold the company's Phase 2b trial of zelnecirnon in atopic dermatitis and its Phase 2a trial in asthma, citing a liver failure event in one patient.
The cause of liver failure is currently unknown but it is allegedly related to zelnecirnon. However, no liver toxicity had been found in other trial patients.
"This is an unfortunate and unexpected event, and we are working diligently to get more information on this case," said Brian Wong, M.D., Ph.D., President and CEO of RAPT Therapeutics. "Patient safety is our top priority and we will work with the FDA to resolve this as quickly as possible."
Currently, RAPT's stock is plummeting 65.59 percent, to $8.97 from the previous close of $25.97 on the Nasdaq.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

FDA Puts Hold On RAPT's Phase 2 Trials For Zelnecirnon In Atopic Dermatitis, Asthma; Stock Tanks 65%

Adds details in paragraphs 2 and 3
Feb 20 (Reuters) - Rapt Therapeutics RAPT.O said on Tuesday the U.S. FDA had placed on hold two mid-stage trials of the company's drug to treat eczema and asthma, after liver failure was observed in one of the patients.
The company said it had enrolled 350 patients across the two mid-stage trials and a previous early-stage study of the drug, zelnecirnon, but no evidence of liver toxicity was observed with any other patient.
Following the hold, Rapt will halt dosing of existing patients and stop enrollment of new participants, while it conducts a thorough investigation of this case.
(Reporting by Leroy Leo and Puyaan Singh in Bengaluru; Editing by Shilpi Majumdar and Devika Syamnath)
((Leroy.Dsouza@thomsonreuters.com ; https://twitter.com/LeroyLeo7;))
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

FDA puts on hold two Rapt Therapeutics mid-stage drug trials

Among the underlying components of the Russell 3000 index, we saw noteworthy options trading volume today in Standard and Poors Global Inc (Symbol: SPGI), where a total of 4,559 contracts have traded so far, representing approximately 455,900 underlying shares. That amounts to about 47.8% of SPGI's average daily trading volume over the past month of 953,440 shares. Especially high volume was seen for the $460 strike call option expiring June 21, 2024, with 2,005 contracts trading so far today, representing approximately 200,500 underlying shares of SPGI. Below is a chart showing SPGI's trailing twelve month trading history, with the $460 strike highlighted in orange:
RAPT Therapeutics Inc (Symbol: RAPT) saw options trading volume of 2,008 contracts, representing approximately 200,800 underlying shares or approximately 47.1% of RAPT's average daily trading volume over the past month, of 426,450 shares. Particularly high volume was seen for the $17.50 strike put option expiring May 17, 2024, with 940 contracts trading so far today, representing approximately 94,000 underlying shares of RAPT. Below is a chart showing RAPT's trailing twelve month trading history, with the $17.50 strike highlighted in orange:
And SL Green Realty Corp (Symbol: SLG) options are showing a volume of 5,996 contracts thus far today. That number of contracts represents approximately 599,600 underlying shares, working out to a sizeable 46.5% of SLG's average daily trading volume over the past month, of 1.3 million shares. Especially high volume was seen for the $37.50 strike put option expiring February 16, 2024, with 1,564 contracts trading so far today, representing approximately 156,400 underlying shares of SLG. Below is a chart showing SLG's trailing twelve month trading history, with the $37.50 strike highlighted in orange:
For the various different available expirations for SPGI options, RAPT options, or SLG options, visit StockOptionsChannel.com.
SPXC Average Annual Return
MNCL market cap history
SPIP Dividend History
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Notable Wednesday Option Activity: SPGI, RAPT, SLG

In trading on Thursday, the Uranium ETF is outperforming other ETFs, up about 3.5% on the day. Components of that ETF showing particular strength include shares of Nexgen Energy, up about 8.3% and shares of Centrus Energy, up about 6.8% on the day.
And underperforming other ETFs today is the SPDR S&P Biotech ETF, down about 2.7% in Thursday afternoon trading. Among components of that ETF with the weakest showing on Thursday were shares of Rapt Therapeutics, lower by about 17.6%, and shares of Coherus Biosciences, lower by about 13.8% on the day.
VIDEO: Thursday's ETF Movers: URA, XBI
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

Thursday's ETF Movers: URA, XBI

Fintel reports that on August 9, 2023, Stifel initiated coverage of RAPT Therapeutics (NASDAQ:RAPT) with a Buy recommendation.
Analyst Price Forecast Suggests 86.11% Upside
As of August 2, 2023, the average one-year price target for RAPT Therapeutics is 42.02. The forecasts range from a low of 21.21 to a high of $64.05. The average price target represents an increase of 86.11% from its latest reported closing price of 22.58.
See our leaderboard of companies with the largest price target upside.
The projected annual revenue for RAPT Therapeutics is 0MM, a decrease of 49.06%. The projected annual non-GAAP EPS is -3.10.
What is the Fund Sentiment?
There are 311 funds or institutions reporting positions in RAPT Therapeutics. This is an increase of 5 owner(s) or 1.63% in the last quarter. Average portfolio weight of all funds dedicated to RAPT is 0.19%, a decrease of 49.36%. Total shares owned by institutions decreased in the last three months by 1.76% to 34,535K shares. The put/call ratio of RAPT is 0.03, indicating a bullish outlook.
What are Other Shareholders Doing?
Price T Rowe Associates holds 3,316K shares representing 9.65% ownership of the company. In it's prior filing, the firm reported owning 3,365K shares, representing a decrease of 1.48%. The firm decreased its portfolio allocation in RAPT by 15.01% over the last quarter.
Column Group holds 2,681K shares representing 7.80% ownership of the company. No change in the last quarter.
Perceptive Advisors holds 2,292K shares representing 6.67% ownership of the company. In it's prior filing, the firm reported owning 1,799K shares, representing an increase of 21.50%. The firm increased its portfolio allocation in RAPT by 24.13% over the last quarter.
PRNHX - T. Rowe Price New Horizons Fund holds 1,906K shares representing 5.55% ownership of the company. In it's prior filing, the firm reported owning 1,907K shares, representing a decrease of 0.07%. The firm decreased its portfolio allocation in RAPT by 12.48% over the last quarter.
Great Point Partners holds 1,355K shares representing 3.95% ownership of the company. In it's prior filing, the firm reported owning 1,437K shares, representing a decrease of 6.01%. The firm decreased its portfolio allocation in RAPT by 12.43% over the last quarter.
RAPT Therapeutics Background Information
(This description is provided by the company.)
RAPT Therapeutics is a clinical stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing its proprietary discovery and development engine, the Company is developing highly selective small molecules designed to modulate the critical immune drivers underlying these diseases. RAPT has discovered and advanced two unique drug candidates, FLX475 and RPT193, each targeting C-C motif chemokine receptor 4 (CCR4), for the treatment of cancer and inflammation, respectively. The Company is also pursuing a range of targets that are in the discovery stage of development.
Additional reading:
This story originally appeared on Fintel.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.