Here's a roundup of top developments in the biotech space over the last 24 hours:
Scaling The Peaks
(Biotech Stocks Hitting 52-week Highs Aug. 26)
- Agenus Inc. AGEN
- Alkermes plc ALKS
- Axonics, Inc. AXNX
- Bio-Techne Corporation TECH
- BioLife Solutions, Inc. BLFS
- Bio-Rad Laboratories, Inc. BIO
- Celldex Therapeutics, Inc. CLDX
- Cerevel Therapeutics Holdings, Inc. CERE
- Clearside Biomedical, Inc. CLSD
- Crinetics Pharmaceuticals, Inc. CRNX
- Cytokinetics, Incorporated CYTK
- Dermata Therapeutics, Inc. DRMA
- Dynavax Technologies Corporation DVAX
- Eliem Therapeutics, Inc. ELYM (IPOed Aug. 10)
- Enanta Pharmaceuticals, Inc. ENTA
- IVERIC bio, Inc. ISEE
- Kezar Life Sciences, Inc. KZR
- Merit Medical Systems, Inc. MMSI
- MiMedx Group, Inc. MDXG
- PDS Biotechnology Corporation PDSB
- Pieris Pharmaceuticals, Inc. PIRS
- Prothena Corporation plc PRTA
- Regeneron Pharmaceuticals, Inc. REGN (reacted to the results of a study showing the company's COVID-19 antibody cocktail was found effective in high-risk COVID-19 patients)
- RenovoRx, Inc. RNXT (IPOed Thursday)
- Repligen Corporation RGEN
- ResMed Inc. RMD
- Syneos Health, Inc. SYNH
- Tenaya Therapeutics, Inc. TNYA
- Verve Therapeutics, Inc. VERV
- West Pharmaceutical Services, Inc. WST
- Zentalis Pharmaceuticals, Inc. ZNTL
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows Aug. 26)
- Absci Corporation ABSI
- Esperion Therapeutics, Inc. ESPR
- IN8bio, Inc. INAB
- Silverback Therapeutics, Inc. SBTX
- Sonnet BioTherapeutics Holdings, Inc. SONN
- Talaris Therapeutics, Inc. TALS
- Theravance Biopharma, Inc. TBPH
- TScan Therapeutics, Inc. TCRX
Stocks In Focus
VectivBio To Buy Rare Inherited Metabolic Disease Biopharma Comet
VectivBio Holding AG VECT said it will acquire Comet Therapeutics, Inc., a privately held company developing drugs to address previously untreatable inherited metabolic diseases. This acquisition significantly expands VectivBio's rare disease pipeline.
Four distinct programs are in research at Comet, with plans to enter the clinic with the first program in the next 18 months.
Sonnet Biotherapeutics Advances Bispecific Compound Into Clinical Study In Melanoma, Renal Cancer Patients
Sonnet Biotherapeutics said it has selected a novel development candidate after completing comparative studies in a mouse melanoma model.
The candidate represents Sonnet's second bispecific compound, and the target indications for SON-1410 will be melanoma and renal cancers. The company plans to submit an investigational new drug application for SON-1410 in the second half of 2022.
The stock was jumping 46.5% to 81.9 cents in premarket trading.
CMS Panel Recommends Higher Reimbursement For Inspire Medical's Procedure
Inspire Medical Systems, Inc. INSP announced Tuesday that a Centers for Medicare and Medicaid Services panel has unanimously approved a recommendation to increase the previously proposed reimbursement for an Inspire procedure performed in Ambulatory Surgical Centers as indicated on the CMS website.
Related Link: The Week Ahead In Biotech (Aug. 29- Sept. 4): Merck's Keytruda Regulatory Decision, Stray Earnings On Tap In a Light Week
Eisai Acquires Rights To Commercialize Excessive Uric Acid Treatment In ASEAN Countries
Eisai Co., Ltd. ESALY and Fuji Yakuhin a license agreement concerning dotinurad, a treatment for hyperuricemia and gout discovered by the latter, for development and distribution in five ASEAN. This agreement conclusion will lead to an expansion into Southeast Asia of an agreement regarding dotinurad in China concluded by Eisai and Fuji Yakuhin in February 2020.
Clinical Study Participants For Novavax Vaccine Considered Fully Vaccinated 2 Weeks After Second Dose
Novavax, Inc. NVAX noted that the updated guidance issued by the U.S. Centers for Disease Control and Prevention said that if a participant in a U.S.-based clinical trial has been documented to have received the full series of an "active" COVID-19 vaccine candidate and vaccine efficacy has been independently confirmed, the participant can be considered fully vaccinated two weeks after they complete the vaccine series.
The company said its COVID-19 vaccine meets this criteria.
The stock was up 0.41% to $234.18 in premarket trading.
Galapagos Co-Founder Steps Down From Role of CEO
Galapagos NV GLPG announced the planned retirement of CEO Onno van de Stolpe, who co-founded the company in 1999 and built and led the company as CEO from its early R&D days through to the commercial launch of filgotinib in Europe.
Van de Stolpe will retire and make way for a new CEO to lead the company going forward and plans to stay on as CEO until a successor is appointed, the company said. The supervisory board has initiated an external search for his replacement.
The stock was up 6.49% to $58.54 in premarket trading.
Opko Health Completes Enrollment Into Phase 2 Study of Rayaldee In Mild-To-Moderate COVID-19 Patients
OPKO Health, Inc. OPK announced the completion of enrollment in its Phase 2 trial with Rayaldee as a treatment for mild-to-moderate COVID-19. The U.S. trial was expected to enroll approximately 160 subjects, including some with Stage 3 or 4 chronic kidney disease, who are at higher risk for developing more severe illness.
Final enrollment reached 171 subjects and topline data is expected later this year.
Talis Biomedical Announces Departure Of CEO
Talis Biomedical Corporation TLIS announced Brian Coe has stepped down as president, CEO and director effective immediately and will continue to work with the company as an advisor.
The company also announced that Kim Popovits has been appointed as interim CEO and will lead the search efforts to hire the company's next president and CEO.
Ligand Gains On Licensee Receiving Regulatory Nod For Zimberelimab In China For Hodgkin's Lymphoma
Ligand Pharmaceuticals, Inc. LGND said its partner Gloria Biosciences has received approval from China's National Medical Products Administration for zimberelimab, an OmniAb-derived anti-PD-1 monoclonal antibody for the treatment of recurrent or refractory classical Hodgkin's lymphoma.
GloriaBio has development and commercialization rights in China with respect to zimberelimab through a sublicense agreement with Ligand's licensee Wuxi Biologics Ireland Limited.
The stock was gaining 5.24%% to $127.49 in premarket trading.
On The Radar
Earnings
- Burning Rock Biotech Limited BNR (before the market open)
- Orphazyme A/S ORPH (before the market open)
- I-Mab IMAB (before the market open)
- Connect Biopharma Holdings Limited CNTB (after the close)
IPOs
Cryo-Cell International, Inc. CCEL, a private cord blood bank, said it will be listed on the Nasdaq as of Tuesday. This is expected to improve the liquidity of Cryo-Cell common stock, broaden its institutional shareholder base and ultimately enhance long-term shareholder value, the company said.
Related Link: Rani Therapeutics, RxSight: 2 Bullish Health Care Stock Picks From BofA
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