Target to $6 from $20
Friday, December 9, 2022
Erasca Oulicenses Its Mid-Stage Cancer Program To Novartis, Raises $100M Via Equity Offering
Erasca Inc (NASDAQ: ERAS) has entered into an exclusive worldwide license agreement with Novartis AG (NYSE: NVS) for naporafenib, a Phase 2 pivotal-ready pan-RAF inhibitor for NRAS mutant (NRASm) melanoma and other RAS/MAPK pathway-driven tumors.
To date, naporafenib has been dosed in over 500 patients across multiple trials and has demonstrated preliminary clinical proof-of-concept and favorable safety and tolerability, Erasca says.
Erasca will pay Novartis a one-time upfront cash payment of $20 million and $80 million in Erasca shares at $6.50 per share.
Novartis is eligible to receive up to $80 million in cash upon achieving regulatory milestones covering two indications in the U.S., Europe, and Japan and up to $200 million in cash upon achieving sales milestones.
Novartis is also eligible to receive a low single-digit percentage royalty on net sales of naporafenib.
As separately announced, Erasca has priced a $100 million equity offering with 15.38 million shares at $6.50/share.
Ambrx Shares Surge After Encouraging Early Safety, Efficacy Data From Breast Cancer Candidate
Ambrx Biopharma Inc (NASDAQ: AMAM) announced preliminary safety and efficacy data from its Phase 2 ACE‑Breast-03 study.
The data presented demonstrated a 51.7% overall response rate (ORR) and 100% disease control rate (DCR) after treatment with ARX788 in HER2-positive mBC patients who are resistant or refractory to T-DM1.
ACE-Breast-03 is a Phase 2 study of ARX788 for patients whose metastatic disease is resistant or refractory to T-DXd, T-DM1, or tucatinib-containing regimens.
Patients had a median time on therapy of 7.2 months, and treatment remains ongoing.
None of the patients experienced drug-related serious adverse events (SAEs), and all adverse events (AEs) were well tolerated, with no treatment discontinuations from AEs.
Two Phase 3 studies and one registration-enabled Phase 2 study with ARX788 conducted by Amrbrx's partner, NovoCodex Biopharmaceuticals, are ongoing in China, with projected readouts in 2023.
Acer Could Win From Key FDA Approvals
One biopharma with an advanced drug candidate well into the regulatory process is Acer Therapeutics. The company's research is focused on serious metabolic diseases that are also exceedingly rare, and lack effective medical treatments. The company’s pipeline currently features three research tracks, with the leading drug candidate, ACER-001, being the farthest along.
ACER-001 is underdevelopment as a treatment for serious ‘inborn errors of metabolism,’ including urea cycle disorders, UCDs, and maple syrup urine disease (MSUD). Acer resubmitted the new drug application (NDA) on -001 to the FDA in July of this year, and is looking at a PDUFA date from the regulatory agency of January 15, 2023.
In June 2022, the FDA already turned down Acer's application to get ACER-001 approved for the treatment of UCDs. The Complete Response Letter (CRL) stated that the FDA field investigator "could not complete inspection" of ACER's third party contract packaging manufacturing location because "the facility was not ready for inspection." The FDA also had one comment in the CRL that was "not an approvability issue" pertaining to a request for additional nonclinical information.
On the insider front, we see a clear case of confidence ahead of the upcoming PDUFA date. First, CEO Steven Lisi laid down $1 million for a bloc of 819,672 shares in his company. The second large buy was from Chairman Steve Aselage who’s 409,836 share purchase cost over $500,000.
5-star analyst Vernon Bernardino, covering Acer for H.C. Wainwright, doesn’t hide his optimism for the stock as well. Bernardino is clear on why Acer has sound prospects ahead, and lays it out in unambiguous prose.
“With no further approvability concerns, we are positive on ACER-001’s prospects for FDA approval on or before January 15, 2023. Thus, we look for ACER-001 to achieve commercial success, and estimate ACER-001 can achieve approximately $750M in annual sales as a treatment for UCDs by 2028. We believe Acer’s accomplishments in meeting the challenges of advancing its NDA, and the potential for ACER-001 to achieve near-term commercial success, are underappreciated,” Bernardino wrote.
Going forward from these comments, Bernardino gives ACER shares a Buy rating, and his $12 price target implies a hefty upside of 664% for the coming year.
Turning now to the rest of the Street, other analysts are on the same page. With 3 Buys and no Holds or Sells, the word on the Street is that ACER is a Strong Buy. The stock has a $9.67 average price target and a share price of $1.57, for a one-year upside potential of ~516%.
https://finance.yahoo.com/news/2-biotech-stocks-under-10-023527396.html
Pfizer and BioNTech Fast Tracked for Single-Dose mRNA-Based Vaccine Candidate Against COVID, Flu
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the companies have received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for their mRNA-based combination vaccine candidate for influenza and COVID-19, which aims to help prevent two respiratory diseases with a single injection. Fast Track is a process designed to facilitate the development and expedite the review of new drugs and vaccines intended to treat or prevent serious conditions and address unmet medical need.1
Pfizer and BioNTech previously announced the start of a Phase 1 trial to examine the safety, tolerability, and immunogenicity of their combined influenza and COVID-19 candidate vaccine among healthy adults.
The vaccine candidate is based on BioNTech’s proprietary mRNA platform technology and contains mRNA strands encoding the wild-type spike protein of SARS-CoV-2 and the spike protein of the Omicron sublineages BA.4/BA.5, as well as mRNA strands encoding the hemagglutinin of four different influenza strains, recommended for the Northern Hemisphere 2022/23 by the World Health Organization.
https://finance.yahoo.com/news/pfizer-biontech-receive-u-fda-114500691.html
FDA Accepts Biogen Biologics License Application for BIIB800, Referencing ACTEMRA
Biogen Inc. (Nasdaq: BIIB) – announced that the U.S. Food and Drug Administration (FDA) has accepted for review the abbreviated Biologics License Application (aBLA) for BIIB800, a biosimilar candidate referencing ACTEMRA®1 (tocilizumab), an anti-interleukin-6 receptor monoclonal antibody.
ACTEMRA® is indicated for several indications, including moderate to severe rheumatoid arthritis in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.
https://finance.yahoo.com/news/fda-accepts-biogen-biologics-license-123000574.html
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