Target to $23 from $27
Friday, January 7, 2022
Supreme Court To Weigh Biden Vaccine Mandate
The Supreme Court on Friday is scheduled to hear at least two hours of arguments beginning at 10 a.m. EST after GOP state officials and business groups filed requests to block President Joe Biden's vaccine mandate for employers who have more than 100 workers, as well as a similar requirement for healthcare facilities.
Justice Sonia Sotomayor has chosen to participate in the arguments from her chambers, and two arguing attorneys, the solicitors general of Ohio and Louisiana, will also participate remotely by telephone, a court spokeswoman said.
The justices spent most of the pandemic working remotely but returned to in-person arguments in October. All nine are fully vaccinated, the court said. The court remains closed to the public due to the pandemic. -Reuters
The plaintiffs have argued that the Biden administration exceeded its authority by imposing requirements that were never authorized by Congress, and that it f ailed to follow the proper administrative rules for issuing emergency regulations.
Of note - and possible relevance to the argument; in July, Biden explicitly stated that people who take the vaccine will not get COVID-19, a statement we know (and knew at the time) was false.
Under one of the Biden policies, OSHA required that businesses employing more than 100 employees need to require vaccinations or weekly testing - which would apply to more than 80 million workers nationwide.
Taking the lead in trying to block the mandate is the state of Ohio and the National Federation of Independent Business. Meanwhile, several religious groups, including the Southern Baptist Theological Seminary, have filed similar cases.
The second policy under consideration by the Supreme Court requires that approximately 10.3 million workers across 76,000 healthcare facilities receive the vaccine.
https://www.zerohedge.com/medical/live-supreme-court-weigh-biden-vaccine-mandate
Amylyx Pharmaceuticals Announces Pricing of Upsized IPO
Amylyx Pharmaceuticals, Inc. (“Amylyx”), a clinical-stage pharmaceutical company working on developing a novel therapeutic for amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases, today announced the pricing of its upsized initial public offering of 10,000,000 shares of common stock pursuant to registration statements on Form S-1 filed with the U.S. Securities and Exchange Commission (“SEC”) at an initial public offering price of $19.00 per share.
All of the shares of common stock are being offered by Amylyx. Amylyx has granted the underwriters a 30-day option to purchase up to an additional 1,500,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions. The gross proceeds to Amylyx from this offering are expected to be $190 million, before deducting underwriting discounts and commissions and offering expenses and excluding any exercise of the underwriters' option to purchase additional shares.
Amylyx' common stock is expected to begin trading on the Nasdaq Global Select Market under the ticker symbol "AMLX" on January 7, 2022. The offering is expected to close on or about January 11, 2022, subject to the satisfaction of customary closing conditions.
Goldman Sachs & Co. LLC, SVB Leerink, and Evercore ISI are acting as joint book-running managers for the offering. H.C. Wainwright & Co. is acting as lead manager for the offering.
Mersana 2022 Strategic Priorities and Milestones
UPLIFT, a single-arm registrational trial of UpRi in platinum-resistant ovarian cancer, expected to complete enrollment in Q3 2022
UP-NEXT, a Phase 3 trial of UpRi monotherapy maintenance in platinum-sensitive ovarian cancer, expected to initiate in Q2 2022
Interim data from UPGRADE dose escalation umbrella trial of UpRi in combination with platinum planned for 2H 2022
Phase 1 dose escalation studies for two first-in-class candidates, XMT-1660, a Dolasynthen B7-H4 targeted ADC and XMT-2056, an Immunosynthen STING-agonist ADC targeting HER2, both expected to initiate in mid-2022
Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, today provided its strategic priorities and anticipated milestones for 2022. Anna Protopapas, President and CEO of Mersana Therapeutics, Inc. will provide a business update at the upcoming virtual 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022.
https://finance.yahoo.com/news/mersana-therapeutics-announces-2022-strategic-130000188.html
Absci Announces Research Collaboration with Merck
Absci Corporation (Nasdaq: ABSI), the drug and target discovery company harnessing deep learning AI and synthetic biology to expand the therapeutic potential of proteins, today announced that it has entered into a research collaboration with Merck (known as MSD outside the United States and Canada), using Absci’s AI-powered Integrated Drug Creation™ Platform.
Under the collaboration, Absci will deploy its Bionic Protein™ non-standard amino acid technology to produce enzymes tailored to Merck’s biomanufacturing applications and receive an upfront and certain other milestone payments. In addition, Merck has the option to nominate up to three targets and enter into a drug discovery collaboration agreement, and Absci would then be eligible to receive up to $610 million in upfront fees and milestone payments for all three targets, as well as research funding and tiered royalties on sales.
https://finance.yahoo.com/news/absci-announces-research-collaboration-merck-100000531.html
Repare Therapeutics: Corporate Update and Milestones Anticipated in 2022
Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, today provided a corporate update and highlighted key milestones anticipated in 2022.
"2021 was a substantial year of progress for Repare. We presented encouraging initial Phase 1 RP-3500 monotherapy data from our Phase 1/2 TRESR trial and began enrollment of patients in our combination trials of RP-3500 with PARP inhibitors and with gemcitabine. We also entered the clinic with our second pipeline program, RP-6306, a first-in-class, oral PKMYT1 inhibitor both as monotherapy and in combination with gemcitabine," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "Our successful follow-on public offering in November of last year secured proceeds that enable us to further advance our innovative pipeline of clinical and preclinical programs through 2023. 2022 is expected to be another exciting year for the Company as we look forward to the data from the expansion cohorts of the TRESR trial in tumors with STEP2 genomic alterations alone and in various combinations. We are looking forward to the initial data from the Phase 1 RP-6306 monotherapy MYTHIC trial and data from additional studies of RP-6306 in combination with chemotherapy agents in advanced solid tumors. We are also on track to initiate IND-enabling studies for our Polθ inhibitor program that will further expand our synthetic lethality-based clinical pipeline."
Key Milestones Anticipated in 2022:
Initiation of a monotherapy Phase 2 TRESR trial of RP-3500, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase), for the treatment of solid tumors with specific synthetic-lethal genomic alterations including those in the ATM gene (ataxia teleangectasia mutated kinase), in tumors with ATM loss of function and in tumors with other STEP2 genomic alteration is expected in the first quarter of 2022;
Initiation of a Phase 1 pediatric module of TRESR trial of RP-3500 monotherapy in children is expected in the first quarter of 2022;
Receipt of monotherapy Phase 1 (Module 1) clinical data from 120 patients enrolled in the Phase 1/2 TRESR (Treatment Enabled by SNIPRx) trial of RP-3500 is expected in the first half of 2022;
Initiation of IND-enabling studies in the Company’s Polθ inhibitor program expected in the first half of 2022;
Determination of recommended Phase 2 dose of RP-3500 in combination with gemcitabine, a trial that began enrolling patients in December 2021, is expected in the second half of 2022; and
Early clinical data readouts for PARPi combination from Phase 1/2 TRESR trial and ATTACC trial of RP-3500 in combination with, collectively, three marketed PARP inhibitors expected in the second half of 2022.
Cash Position and Financial Guidance
Repare ended the third quarter of 2021 with approximately $268.2 million in cash and cash equivalents. In November 2021, the Company closed an upsized underwritten follow-on public offering yielding aggregate gross proceeds of approximately $101.2 million, or net proceeds of approximately $93.9 million, after deducting underwriting commissions and estimated offering expenses of $1.2 million. The Company expects that its cash and cash equivalents will be sufficient to fund its planned operations through 2023.
Upcoming Presentation at 40th Annual J.P. Morgan Healthcare Conference
Repare Therapeutics will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:45 p.m. Eastern Time. A live webcast of the presentation can be accessed in the Investor section of the Company’s website at https://ir.reparerx.com/news-and-events/events. A replay of the webcast will be archived on the Company’s website for 30 days.
Revance: Prelim Q4, FY Results and Corporate Update
Preliminary unaudited Q4 RHA® Collection revenue of between $23.0 million and $24.0 million
Preliminary unaudited cash, cash equivalents, and short-term investments of approximately $225 million as of December 31
Preliminary unaudited full year GAAP and Non-GAAP operating expenses to be on the low end of or below the previously announced guidance ranges of $375 million to $390 million and $270 million to $285 million, respectively
Type A Meeting held with FDA regarding DaxibotulinumtoxinA for Injection; Update to be provided upon receipt of meeting minutes
FDA approved RHA® Redensity dermal filler for the treatment of perioral rhytids (lip lines) on December 22, 2021
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