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 30)
- Gain Therapeutics, Inc. GANX
- Varian Medical Systems, Inc. VAR
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows March 30)
- 4D Molecular Therapeutics, Inc. FDMT
- 4D pharma plc LBPS
- Akouos, Inc. AKUS
- ADMA Biologics, Inc. ADMA
- Aprea Therapeutics, Inc. APRE
- Assembly Biosciences, Inc. ASMB
- Avidity Biosciences, Inc. RNA
- Calithera Biosciences, Inc. CALA
- Coherus BioSciences, Inc. CHRS
- ContraFect Corporation CFRX (reacted to its fourth-quarter results)
- Decibel Therapeutics, Inc. DBTX (announced its fourth-quarter results)
- Evaxion Biotech A/S EVAX
- Evofem Biosciences, Inc. EVFM
- Forma Therapeutics Holdings, Inc. FMTX (reacted to its fourth-quarter results)
- Freeline Therapeutics Holdings plc FRLN
- Frequency Therapeutics, Inc. FREQ (announced its fourth-quarter results)
- Fusion Pharmaceuticals Inc. FUSN
- Galecto, Inc. GLTO
- Gracell Biotechnologies Inc. GRCL
- IMARA Inc. IMRA
- Karyopharm Therapeutics Inc. KPTI
- Landos Biopharma, Inc. LABP
- Lucira Health, Inc. LHDX
- Metacrine, Inc. MTCR
- Millendo Therapeutics, Inc. (MLND)
- MorphoSys AG MOR
- Olema Pharmaceuticals, Inc. OLMA
- PMV Pharmaceuticals, Inc. PMVP
- PolyPid Ltd. PYPD
- Relay Therapeutics, Inc. RLAY
- Repro Med Systems, Inc. KRMD
- Qualigen Therapeutics, Inc. QLGN
- Sarepta Therapeutics, Inc. SRPT
- Sensei Biotherapeutics, Inc. SNSE
- Spruce Biosciences, Inc. SPRB
- SQZ Biotechnologies Company SQZ
- Wave Life Sciences Ltd. WVE ( announced termination of studies of two investigational assets that were being evaluated for Huntington's disease)
- Zymeworks Inc. ZYME
Stocks In Focus
Amgen to Buy Tissue Repair and Regeneration Company Rodeo For Up to $721 Million In Cash
Amgen Inc. AMGN announced an agreement to acquire Rodeo Therapeutics, a privately held biopharma, for a $55 million upfront payment as well as future contingent milestone payments potentially worth up to an additional $666 million in cash.
The transaction has been approved by the shareholders and the boards of Rodeo.
Seattle-based Rodeo develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. Amgen sees Rodeo's 15-PGDH program as a strong strategic fit with its inflammation portfolio.
Equillium Reports Positive Results For Early-stage Study of Antibody Drug to Treat Autoimmune Disease
Equillium, Inc. EQ announced positive topline data from the Type A group of the EQUALISE Phase 1b study that evaluated itolizumab in patients with systemic lupus erythematosus. Itolizumab, a monoclonal antibody selectively targeting the CD6-ALCAM pathway, was found to be safe and well-tolerated and also demonstrated a dose-dependent reduction of cell surface CD6 expression on effector T cells, a leading indicator of drug activity, consistent with its mechanism of action.
The stock gained 7.41% to $7.10 in after-hours trading.
Surface Oncology's Cancer Drug Gets Orphan Drug Designation
Surface Oncology, Inc. SURF said the Food and Drug Administration granted orphan drug designation for one of its lead therapeutic candidates, SRF617, for the treatment of patients with pancreatic cancer.
SRF617 is in Phase 1/1b studies across a variety of solid tumors, including combination studies with gemcitabine and abraxane in patients with pancreatic cancer.
The stock was up 19.45% to $8.66 in after-hours trading.
Pfizer-BioNTech COVID-19 Vaccine 100% Effective In Adolescent Population
Pfizer Inc. PFE and its German partner BioNTech SE BNTX said in a Phase 3 trial in adolescents 12 to 15 years of age with or without prior evidence of SARS-CoV-2 infection, their COVID-19 vaccine BNT162b2 demonstrated 100% efficacy and robust antibody responses. The efficacy exceeded those recorded earlier in vaccinated participants aged 16 to 25 years old.
Opthea Gets Pediatric Study Waiver For Lead Drug In Wet Age-related Macular Degeneration
Opthea Limited OPT said it has received an initial Pediatric Study Plan waiver from the FDA for OPT-302, its lead product candidate currently in Phase 3 clinical development for the treatment of neovascular or wet age-related macular degeneration.
The receipt of the agreed iPSP waiver means the company will not have to conduct an additional study in the pediatric population.
The stock was up 5.51% to $9.31 in premarket trading Wednesday.
Chinook to Delay Filing of its Annual Report
Chinook Therapeutics, Inc. KDNY said in a filing it's not in a position to file its annual report on Form 10-K as it requires additional time to complete purchase accounting and merger-related disclosures related to its recently concluded business combination with Aduro Biotech. The company said the report will be filed no later than the 15th calendar day following March 31.
The stock fell 4.42% to $16 in after-hours trading.
Regeneron Announces Publication of Positive Long-term Data For Eylea In Diabetic Retinopathy
Regeneron Pharmaceuticals, Inc. REGN announced publication in JAMA Ophthalmology positive initial results from the NIH-sponsored trial that is evaluating Eylea injection in patients with moderate to severe non-proliferative diabetic retinopathy.
At two years, there was a 68% reduced risk of developing vision-threatening complications in patients who received Eylea, every-16-weeks dose regimen. On the other hand, patients receiving sham injections were about five times more likely to experience disease progression, requiring Eylea rescue therapy.
Eylea received label expansion to include diabetic retinopathy among the approved indications in May 2019.
Jazz' Blood Cancer Drug Approved by FDA For Additional Indication
Jazz Pharmaceuticals plc JAZZ said the FDA approved a revised label for Vyxeos to include a new indication to treat newly-diagnosed therapy-related acute myeloid leukemia with myelodysplasia-related changes in pediatric patients aged one year and older.
Exelixis' Cabometyx Combo Therapy Approved In Europe For Advanced Kidney Cancer
Exelixis, Inc. EXEL said its partner Ipsen received approval from the European Commission for Cabometyx in combination with Bristol-Myers Squibb Company's BMY Opdivo as a first-line treatment for advanced renal cell carcinoma.
This approval allows for the marketing of Cabometyx in combination with Opdivo in this indication in all 27 member states of the European Union, Norway, Iceland and Liechtenstein.
Kamada Announces Positive Results From Phase 1/2 Study of Plasma-derived Hyperimmune Globulin Treatment For COVID-19
Kamada Ltd. KMDA announced topline results from the Phase 1/2 study in Israel of its anti-SARS-CoV-2 plasma-derived hyperimmune globulin treatment for coronavirus disease, showing IgG levels in the plasma of all patients increased.
Preliminary results demonstrated that the IgG level increase was associated with enhanced neutralization activity. The IgG product also demonstrated a favorable safety profile.
EDAP TMS S.A. EDAP reported a 28% year-over-year increase in fourth-quarter revenues to $18.3 million. The net loss per share remained flat with the year-ago quarter.
In after-hours trading, the stock slipped 9.66% to $8.70.
Bellicum Pharmaceuticals, Inc. BLCM reversed from a loss of $5.82 per share in the fourth quarter of 2020 to a profit of 98 cents per share in year-ago quarter.
The stock was up 9.17% to $3.69 in after-hours trading.
Eledon Pharmaceuticals, Inc.'s ELDN fourth-quarter loss narrowed from $5.75 per share in 2019 to $2.13 in 2020.
The stock soared 23.86% to $12.20 in after-hours trading.
ProQR Therapeutics N.V. PRQR priced its previously announced underwritten public offering of 13.846 million ordinary shares at a price of $6.50 per share. All of the shares are being offered by ProQR.
The stock was down 4.49% at $6.81 in after-hours trading.
Humanigen, Inc. HGEN priced its underwritten public offering of 5 million shares of its common stock at $18.50 per share, resulting in gross proceeds to the company of approximately $92.5 million.
The stock slipped 2.51% to $21.13 in after-hours trading.
On The Radar
Apyx Medical Corporation APYX (before the market open)
Delcath Systems, Inc. DCTH (before the market open)
BiomX Inc. PHGE (before the market open)
Precipio, Inc. PRPO (after the close)
Rockwell Medical, Inc. RMTI (after the close)
U.K.-based Achilles Therapeutics plc priced its initial public offering of 9.75 million ADSs at $18 per ADS, at the middle of the estimated price range of $17-$19. The company expects to raise gross proceeds of $175.5 million from the offering.
The shares of clinical stage immuno-oncology company developing precision T cell therapies to treat multiple types of solid tumors will begin trading on the Nasdaq under the ticker symbol ACHL.
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