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 June 30)
- Ambrx Biopharma Inc. AMAM (announced the appointment of Sonja Nelson as CFO)
- Avid Bioservices, Inc. CDMO (reacted to its quarterly results)
- Beam Therapeutics Inc. BEAM
- Century Therapeutics, Inc. IPSC
- Codex DNA, Inc. DNAY
- Cyteir Therapeutics, Inc. CYT
- Graphite Bio, Inc. GRPH (IPOed Friday)
- Harvard Bioscience, Inc. HBIO
- I-Mab IMAB
- Intellia Therapeutics, Inc. NTLA
- Moderna, Inc. MRNA
- Vanda Pharmaceuticals Inc. VNDA
- Verve Therapeutics, Inc. VERV
- Zoetis Inc. ZTS
Down In The Dumps
(Biotech Stocks Hitting 52-week Lows June 30)
- Achilles Therapeutics plc ACHL
- Athersys, Inc. ATHX
- Global Blood Therapeutics, Inc. GBT
- IMV Inc. IMV
- Inhibikase Therapeutics, Inc. IKT
- Innate Pharma S.A. IPHA
- Kiromic BioPharma, Inc. KRBP (priced its 8-million-share common stock offering)
- Madrigal Pharmaceuticals, Inc. MDGL
- Medicenna Therapeutics Corp. MDNA
- Mersana Therapeutics, Inc. MRSN
- Neoleukin Therapeutics, Inc. NLTX
- Tempest Therapeutics, Inc. TPST
- Terns Pharmaceuticals, Inc. TERN
- Theravance Biopharma, Inc. TBPH
- VectivBio Holding AG VECT
- Vivos Therapeutics, Inc. VVOS
Stocks In Focus
Spero Gets $40M Equity Funding From Pfizer, Out-Licenses Antibiotic Drug
Spero Therapeutics, Inc. SPRO announced that Pfizer Inc. PFE has made a $40-million equity investment in Spero as part of the Pfizer Breakthrough Growth Initiative to fund innovative science to meet patient needs.
Spero intends to use the proceeds from the equity investment to prepare for the potential approval and launch of tebipenem HBr, as well as to support the continued clinical development of SPR720 and SPR206.
The companies have also entered into a licensing agreement for SPR206, Spero's intravenously administered next-generation polymyxin product candidate being developed to treat serious multi-drug resistant gram-negative infections in the hospital setting.
The licensing pact allows Spero to receive up to $80 million in development and sales milestones, and high single digit to low double-digit royalties on net sales of SPR206 in these territories.
Spero shares were soaring 31.09% to $18.30 in premarket trading.
Beam, Apellis Enter 5-Year R&D Collaboration Targeting Complement-Driven Diseases
Beam and Apellis Pharmaceuticals, Inc. APLS announced an exclusive five-year research collaboration focused on the use of Beam's proprietary base editing technology to discover new treatments for complement-driven diseases. The companies will collaborate on six research programs focused on C3 and other complement targets in the eye, liver and brain.
Under the terms of the collaboration agreement, Apellis will have exclusive rights to license each of the six programs being evaluated in preclinical trials by Beam and will assume responsibility for subsequent development.
Beam stands to receive a total of $75 million in upfront and near-term milestones from Apellis. After exercise of the opt-in license rights for each of the up to six programs, Beam will be eligible to receive development, regulatory and sales milestones from Apellis, as well as royalty payments on sales.
Beam shares were up 0.61% at $129.50 in premarket trading.
CureVac Final Vaccine Efficacy Data Confirm Preliminary Findings
CureVac N.V. CVAC announced results from the final analysis of its 40,000-subject international pivotal Phase 2b/3 study, dubbed HERALD, of the first-generation COVID-19 vaccine candidate, CVnCoV, which confirmed overall vaccine efficacy at 48% against COVID-19 disease of any severity, including single non-respiratory mild symptoms.
The results confirmed the findings from the interim analysis of the data reported in mid-June.
The stock was down 12.55% to $64.26 in premarket trading.
Jazz's Alternative Component For Chemo Regiment In Blood Cancer Lands FDA Approval
Jazz Pharmaceuticals plc JAZZ announced FDA approval for its Rylaze for use as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia or lymphoblastic lymphoma in pediatric and adult patients one month and older who have developed hypersensitivity to E. coli-derived asparaginase.
Rylaze is the only recombinant erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment, the company said.
Jazz said Rylaze will be commercially available in mid-July.
Mesoblast Files For Type C Meeting With FDA For Approval of Stem Cell Therapy To Treat Chronic Lower Back Pain
Mesoblast Limited MESO said it has filed a request and expects to hold a Type C meeting with the FDA during the current quarter to discuss the pathway to U.S. regulatory approval for rexlemestrocel-L in patients with chronic low back pain.
"We look forward to discussing with the FDA the most efficient path forward given the durable pain reduction for at least two years and the opioid-sparing activity from a single administration of rexlemestrocel-L that was observed in the recent Phase 3 trial," said Dr. Fred Grossman, Mesoblast's chief medical officer.
The stock was gaining 18.45% at $8.86 in premarket trading.
Novavax Announces Publication Of Positive Data From Final Analysis Of UK Phase 3 Vaccine Trial
Novavax, Inc. NVAX announced publication in the New England Journal of Medicine results from the final analysis of a pivotal Phase 3 clinical trial of its COVID-19 vaccine candidate conducted in the U.K., confirming an overall efficacy of 89.7%, with over 60% of the cases caused by the B.1.1.7 variant, and 96.4% efficacy against non-B.1.1.7 variants, representing strains most similar to the original virus.
In premarket trading, the stock was up 2.68% at $218.
Biophytis Strikes COVID-19 Treatment Manufacturing Deal With CDMO, Issues Timeline For Conditional Approval
Biophytis SA ALBPS said it has secured contracts with a major global custom development and manufacturing organization for the manufacturing of registration batches of Sarconeos, which is being evaluated in patients aged 45 and older who are hospitalized with severe respiratory manifestations of COVID-19.
These contracts, the company said, were signed in preparation of the potential filing of the product in COVID-19 for emergency use authorization with FDA, or conditional marketing authorization with the European Medicines Agency.
The company also said the 155th patient has completed treatment in Part 2 of the COVA Phase 2/3 study, and results of second interim analysis are expected in the third quarter. The full results of the study and the filing for market authorization are now scheduled for the fourth quarter.
In premarket trading, the stock was adding 3.87% to $11.
Orchard, Pharming Ink Gene Therapy Collaboration For Hereditary Angioedema Treatment
Gene therapy company Orchard Therapeutics ORTX and Pharming Group N.V. PHAR announced a strategic collaboration to research, develop, manufacture and commercialize OTL-105, a newly disclosed investigational ex vivo autologous hematopoietic stem cell gene therapy for the treatment of hereditary angioedema.
Under the terms of the collaboration, Pharming has been granted worldwide rights to OTL-105 and will be responsible for clinical development, regulatory filings and commercialization of the investigational gene therapy, including associated costs.
The agreement provides for Orchard receiving an upfront payment of $17.5 million — comprising $10 million in cash and a $7.5-million equity investment from Pharming — at a premium to Orchard's recent share price.
Orchard is also eligible to receive up to $189.5 million in development, regulatory and sales milestones as well as mid-single to low double-digit royalty payments on future worldwide sales.
Orchard shares were up 8.66% at $4.77 in premarket trading.
Alzamend Submits Regulatory Application For Commencing Human Trial of Alzheimer's Treatment
Alzamend Neuro, Inc. ALZN said it submitted an investigational new drug application to the FDA for the initiation of a Phase 1 clinical study of AL001 Wednesday.
AL001 is a lithium-based ionic cocrystal oral therapy for patients with dementia related to mild, moderate and severe cognitive impairment associated with Alzheimer's disease.
The stock was up 8.47% at $9.48 in premarket trading.
Immunic Gets FDA Clearance For Starting Phase 3 Study of Multiple Sclerosis Drug
Immunic, Inc. IMUX said it has received FDA clearance for its investigational new drug application for the Phase 3 ENSURE program of lead asset IMU-838 in patients with relapsing-remitting multiple sclerosis. In addition, the FDA also cleared the company's separate IND application for the supportive phase 2 CALLIPER trial of IMU-838 in patients with progressive multiple sclerosis.
In premarket trading Thursday, the stock was moving up 6.04% to $13.
On The Radar
Affimed N.V. AFMD (before the market open)
Acumen Pharmaceuticals, Inc., a clinical-stage biopharma working on Alzheimer's disease treatment, priced its upsized initial public offering of 10 million shares at $16, at the higher end of the estimated price range of $14-$16. Shares of the Charlottesville, Virginia-based company will begin trading on the Nasdaq under the ticker symbol "ABOS."
POINT Biopharma Inc., a company working on radiopharmaceuticals, announced the completion of its business combination with Therapeutics Acquisition Corp. RACA, a SPAC sponsored by RA Capital Management.
The combined company, will commence trading on the Nasdaq under the ticker symbol "PNT" on Thursday.
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