Author: Vandana Singh

[ad_1] Regeneron Pharmaceuticals Inc REGN has agreed to acquire Decibel Therapeutics Inc DBTX at $4.00 per share with an additional contingent value right of up to $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for Decibel’s lead investigational candidate, DB-OTO, within specified time periods. The proposed acquisition values Decibel at a total equity value of approximately $109 million and approximately $213 million if the CVR milestones are achieved.Decibel and Regeneron established their initial collaboration in 2017, with an extension announced in 2021, and are developing three gene therapy programs targeting different forms of congenital, monogenic hearing loss. DB-OTO, currently in…

[ad_1] Shares of Novavax Inc NVAX after reported Q2 revenue of $424 million, compared to $186 million a year ago, beating the consensus of $257.62 million.The company is on track with its global restructuring and cost reduction plan. It reiterates its target to reduce annual combined R&D and SG&A expenses by approximately 20%-25% in 2023 versus 2022 and by approximately 40%-50% in 2024 versus 2022.The company reported an EPS income of $0.58, a turnaround from an EPS loss of $(6.53) a year ago, beating the consensus estimate of $(1.24).Novavax CEO John Jacobs told CNBC that the company pulled forward some sales that “might have drifted” into…

[ad_1] The FDA approved Sage Therapeutics Inc SAGE and Biogen Inc’s BIIB Zurzuvae (zuranolone) 50 mg for adults with postpartum depression (PPD) but issued a Complete Response Letter for the New Drug Application for zuranolone for major depressive disorder.The CRL stated that the application did not provide substantial evidence of effectiveness to support the approval of zuranolone for the treatment of MDD and that additional study or studies will be needed. Wedbush says it is difficult to imagine Biogen investing in additional trials as their turnaround efforts unfold. Further clarity from the agency will likely be needed to make a call. For Biogen, the analyst Laura Chico lowered…

[ad_1] Nautic Partners agreed to acquire Tabula Rasa HealthCare Inc TRHC for $10.50 in cash per share and combine with ExactCare Pharmacy, a portfolio company of Nautic. The all-cash transaction values Tabula Rasa at approximately $570 million including net debt of approximately $262 million on an enterprise value basis.Following the closing of the transaction, John Figueroa, ExactCare’s current Executive Chairman, will assume the role of Chairman and CEO of the combined company. The transaction is expected to close during Q4 of 2023.The deal expands the reach of Tabula Rasa’s MedWise technology platform to multiple provider and payer markets.Tabula Rasa HealthCare reported Q2 adj EPS of $0.03, beating…

[ad_1] Nektar Therapeutics Inc NKTR said its former partner Eli Lilly And Co LLY had presented “erroneous data” from two Phase 1b studies of its atopic dermatitis drug, rezpegaldesleukin (Rezpeg).The new and corrected data from the atopic dermatitis study demonstrate that 12 weeks of REZPEG therapy at the highest dose resulted in a mean Eczema Area and Severity Index (EASI) score improvement of 83% with a p-value of 0.002 as compared to placebo and an EASI-75 response rate of 41%, versus 66% and 29% on the original analysis.Rezpeg also provided a more rapid and steep drop in EASI scores immediately after therapy initiation than the previously…

[ad_1] Axsome Therapeutics Inc AXSM reported Q2 sales of $46.7 million, beating the consensus of $40.19 million. The company reported a Q2 EPS loss of $(1.54), missing the consensus of $(1.24).Sales from Auvelity, a prescription oral medicine used to treat adults with major depressive disorder (MDD), reached $27.6 million, up 76% sequentially. There were no Auvelity sales in the comparable 2022 period as the product was launched in October 2022.Approximately 53,000 prescriptions were reported for Auvelity in Q2, up 72% sequentially.Sunosi’s revenue was $19.1 million, consisting of $18.4 million in net product sales and $0.7 million in royalty revenue associated with Sunosi sales in…

[ad_1] Viatris Inc VTRS reported Q2 FY23 sales of $3.91 billion, up 2% on a divestiture-adjusted operational basis, marginally higher the consensus of $3.89 billion.Brands performed in line with expectations, reflecting strong year-over-year performance in key brands, including Yupelri and sales from Tyrvaya.Complex generics performed in line with expectations.The company generated approximately $124 million in new product revenues in Q2, primarily driven by lenalidomide in the U.S., and is on track to achieve approximately $500 million in new product revenues in 2023.Generics, which include diversified product forms such as oral solids, injectables, transdermals, and topicals, performed ahead of expectations due to strong performance…

[ad_1] BioNTech SE BNTX has reported Q2 revenues of €167.7 million, sharply down from €3.2 billion a year ago. For the six months ended June 30, 2023, total revenues were €1.44 billion, compared to €9.6 billion for the comparative prior year period. Write-offs by BioNTech’s collaboration partner Pfizer Inc PFE significantly reduced the company’s gross profit share in the second quarter and negatively influenced its Q2 revenues.Cash and cash equivalents and security investments were €14.17 billion and €2.7 billion, respectively.After the end of the reporting period, the payment settling BioNTech’s gross profit share for Q1 of 2023 (as defined by the contract with Pfizer) in the amount…

[ad_1] The FDA approved Sage Therapeutics Inc SAGE and Biogen Inc’s BIIB Zurzuvae (zuranolone) 50 mg for adults with postpartum depression (PPD). Zurzuvae is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD. Until now, the FDA said, treatment for postpartum depression was available only as an intravenous injection.Zurzuvae is expected to launch and be commercially available in the fourth quarter of 2023, shortly following scheduling as a controlled substance by the U.S. Drug Enforcement Administration, which is anticipated to occur within 90 days.Postpartum depression (PPD) approval is based on results from two Phase 3 trials, ROBIN…

[ad_1] iRhythm Technologies Inc’s IRTC revenue of $124.1 million increased 21.6% Y/Y, beating the consensus of $120.34 million.The increase was driven by volume growth of Zio services, partially offset by a decline in net average selling price.The company reported adjusted EPS loss $(0.43), beating the consensus estimate of $(0.78)The gross margin of 69.5% is a 70-basis point improvement compared to the second quarter of 2022.Cash, cash equivalents, and marketable securities of $164.7 million as of June 30, 2023Guidance: iRhythm projects FY23 revenue to grow approximately 18%-19% Y/Y, ranging from approximately $485 million to $490 million compared to previous guidance of $480 million-$490 million and the consensus of…