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 March 29)
- Edgewise Therapeutics, Inc. EWTX (went public Friday)
- Gain Therapeutics, Inc. GANX
- GW Pharmaceuticals plc GWPH
- Universe Pharmaceuticals INC UPC
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows March 29)
- 4D Molecular Therapeutics, Inc. FDMT
- AbCellera Biologics Inc. ABCL
- Adagene Inc. ADAG
- ADMA Biologics, Inc. (ADMA)
- Avidity Biosciences, Inc. RNA
- Bellerophon Therapeutics, Inc. BLPH
- Chiasma, Inc. CHMA
- Decibel Therapeutics, Inc. DBTX
- Epizyme, Inc. EPZM
- Evaxion Biotech A/S EVAX
- Freeline Therapeutics Holdings plc FRLN
- Fusion Pharmaceuticals Inc. FUSN
- Gracell Biotechnologies Inc. GRCL
- IMARA Inc. IMRA
- Kala Pharmaceuticals, Inc. KALA
- Karyopharm Therapeutics Inc. KPTI
- Landos Biopharma, Inc. LABP
- Lava Therapeutics B.V. LVTX (went public Friday)
- Lucira Health, Inc. LHDX
- Longeveron Inc. LGVN
- MorphoSys AG MOR
- Olema Pharmaceuticals, Inc. OLMA
- Oncorus, Inc. ONCR
- Orphazyme A/S ORPH (the company's arimoclomol flunked a Phase 2/3 study in patients with body myositis, a progressively debilitating muscle-wasting disease)
- PMV Pharmaceuticals, Inc. PMVP
- Prometheus Biosciences, Inc. RXDX
- Relay Therapeutics, Inc. RLAY
- Repro Med Systems, Inc. KRMD
- Sarepta Therapeutics, Inc. SRPT
- Sensei Biotherapeutics, Inc. SNSE
- Spruce Biosciences, Inc. SPRB
- Talis Biomedical Corporation TLIS
- SQZ Biotechnologies Company SQZ
Stocks In Focus
Wave Life Sciences Stops Development Of 2 Huntington's Disease Drug Candidates After Failed Study
Wave Life Sciences Ltd. WVE announced data from the Phase 1b/2a trials evaluating investigational treatments WVE-120102 and WVE-120101, in Huntington's disease, showing both candidates did not produce statistically significant change in mutant huntingtin protein versus placebo after single or multiple doses.
The company said it will stop the study of both candidates and instead focus on WVE-120103.
WVE-120103, the company said, will be advanced into a Phase 1b/2a Huntington's disease study. The investigational asset uses new PN backbone chemistry modifications that demonstrate improved preclinical pharmacology, the company said.
The stock was down 26.8% premarket at $5.19.
Merck's Application For Keytruda-Chemo Combo Label Expansion In Early Stage Breast Cancer Hit With Rejection
Merck & Co., Inc. MRK said the Food and Drug Administration has issued a complete response letter regarding its supplemental biologics license application seeking approval for Keytruda for the treatment of patients with high-risk, early stage triple-negative breast cancer in combination with chemotherapy as a pre-operative treatment option, then continuing as a single agent as a post-operative treatment option after surgery.
The company said it is reviewing the letter and will discuss next steps with the FDA.
Tiziana Plans Phase 2 Study Of Lead Drug In COVID-19
Tiziana Life Sciences PLC TLSA said it plans to advance development of Foralumab, its anti-CD3 human monoclonal antibody, into a Phase 2 COVID-19 study.
The decision follows a recent clinical study in mild-to-moderate COVID-19 patients, which showed evidence that the nasally administered anti-CD3 monoclonal antibody reduced pulmonary and systemic inflammation and was well-tolerated.
Since the anti-inflammatory effect of nasally administered Foralumab is through the modulation of the immune system and not by directly targeting COVID-19, it is likely to be effective against the newly identified strains of the coronavirus in the U.K., South Africa and Brazil, the company said.
The stock was up 4.91% to $2.78 in premarket trading Tuesday.
GlaxoSmithKline Agrees To Support Manufacturing of Novavax's COVID-19 Vaccine In UK
GlaxoSmithKline plc GSK, Novavax, Inc. NVAX and the U.K. Government Vaccines Taskforce announced an agreement in principle to support manufacturing of up to 60 million doses of Novavax's COVID-19 vaccine candidate NVX-CoV2373 for use in the U.K.
GlaxoSmithKline will provide "fill and finish" manufacturing capacity at its Barnard Castle facility in the northeast of England beginning as early as May. The companies will negotiate a final agreement with additional terms and conditions.
In premarket trading Tuesday, Novavax shares were edging down 1.01% to $172 and GlaxoSmithKline was retreating 1.09% to $36.29.
Amarin's Vascepa Approved In Europe As Vazkepa
Amarin Corporation plc AMRN said the European Medicines Agency has approved the marketing authorization application for Vazkepa to reduce the risk of cardiovascular events in high-risk, statin-treated adult patients who have elevated triglycerides.
Vazkepa, which goes by the brand name Vascepa in the U.S., was approved by the FDA in December 2019.
The stock was advancing 3.75% to $6.36 premarket Tuesday.
Roche's Spinal Muscular Dystrophy Drug Approved In Europe
Roche Holding AG RHHBY said the European Commission has approved Evrysdi for the treatment of 5q spinal muscular atrophy in patients two months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.
The condition causes muscle weakness and progressive loss of movement, and a significant unmet need remains, particularly in adults living with the condition.
Roche is leading the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics, Inc. PTCT. Evrysdi was approved by the U.S. FDA in August 2020.
Novartis Inks Deal To In-License Radioligand Therapy Assets Targeting Cancer, Gets European Nod For Multiple Sclerosis Drug
Novartis AG NVS said it has obtained exclusive worldwide rights to develop and commercialize therapeutic applications for a library of fibroblast activation protein-targeting agents including FAPI-46 and FAPI-74, through an assignment agreement with iTheranostics, Inc., an affiliate of SOFIE Biosciences, Inc.
The FAP assets were originally developed at the University of Heidelberg. The agreement also includes co-exclusive rights for Novartis to develop imaging applications for these assets.
Separately, Novartis received European Commission marketing authorization for the use of Kesimpta in the treatment of relapsing forms of multiple sclerosis in adults with active disease defined by clinical or imaging features.
Kesimpta, which is developed and marketed worldwide by Novartis under a license agreement with Genmab A/S GMAB, is the first B-cell therapy that can be self-administered once-monthly at home via the Sensoready autoinjector pen.
Kezar Rises On Insider Buying
Kezar Life Sciences, Inc. KZR disclosed in a filing that Vassiliki Economides, its SVP of strategy and external affairs, bought 750 shares of the company at $10.19 per share.
The stock rose 10.18% to $6.17 in after-hours trading.
AbCellera's full-year 2021 revenue climbed 1,908% to $233.2 million, with the bulk of the increase due to royalty revenue of $198.3 million for its anti-COVID-19 antibody treatment bamlanivimab, which it has licensed to Eli Lilly and Company LLY. The company reversed to a profit of 45 cents per share from a loss of 1 cent per share.
The stock jumped 14.13% premarket to $26.58.
Vaxcyte, Inc. PCVX reported a narrower loss of 41 cents per share for the fourth quarter of 2020. This was notably smaller than the loss of $3.69 per share reported for the year-ago quarter. Analysts had estimated a loss of 54 cents per share for the quarter.
The stock was down 11.13% premarket at $20.20.
Biocept, Inc.'s BIOC fourth-quarter revenue increased from $1.8 million in 2019 to $18.5 million in 2020.
The company reversed from a loss of $1.97 per share in the year-ago quarter to a profit of 14 cents per share. Analysts, on average, were estimating a loss of 27 cents per share for the quarter.
The stock was up 16.7% premarket at $6.01.
Celldex Therapeutics, Inc. (CLDX) reported fourth-quarter revenue of $3.8 million in 2020, up 322% year-over-year, with the increase primarily due to a $1.8-million milestone payment from the Rockefeller University.
The loss per share narrowed from 64 cents to 55 cents. The company said it has sufficient cash runway to see it through 2023.
The stock was down 8.4% premarket at $18.75.
Cellectis S.A. CLLS said it has filed a prospectus supplement with the SEC relating to an at-the-market program, pursuant to which it may offer and sell to eligible investors a total gross amount of up to $125 million of ADS, with each ADS representing one ordinary share of Cellectis.
Applied Molecular Transport Inc. AMTI said it has commenced an underwritten public offering of 2.5 million shares of its common stock. All of the shares in the proposed offering will be sold by the company.
The stock fell 1.72% to $48 in after-hours trading.
On The Radar
- BioNTech SE BNTX (before the market open)
- PolarityTE, Inc. PTE (before the market open)
- Pieris Pharmaceuticals, Inc. PIRS (before the market open)
- Immatics N.V. IMTX (before the market open)
- Forma Therapeutics Holdings, Inc. FMTX (before the market open)
- Protalix BioTherapeutics, Inc. PLX (before the market open)
- AngioDynamics, Inc. ANGO (before the market close)
- Bellicum Pharmaceuticals, Inc. BLCM (after the close)
- Daré Bioscience, Inc. DARE (after the close)
- IGM Biosciences, Inc. IGMS (after the close)
- Osmotica Pharmaceuticals plc OSMT (after the close)
- EDAP TMS S.A. EDAP (after the close)
- Dyadic International, Inc. DYAI (after the close)
- INVO Bioscience, Inc. INVO (after the close)
- CorMedix Inc. CRMD (after the close)
- Spectrum Pharmaceuticals, Inc. SPPI (after the close)
- Eledon Pharmaceuticals, Inc. ELDN (after the close)
- Crinetics Pharmaceuticals, Inc. CRNX (after the close)
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