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Monday, September 11, 2023

Moderna, Immatics to work jointly on cancer vaccines

 Vaccine maker Moderna said on Monday it had struck a deal with Immatics for developing cancer vaccines and therapies and would pay the drug developer $120 million in cash and additional milestone payments.

Moderna said the companies intend to combine Immatics' T-cell redirecting cancer therapies with its mRNA technology.

Immatics will also receive research funding and is eligible to receive development, regulatory, and commercial milestone payments that could exceed $1.7 billion, Moderna said.

https://finance.yahoo.com/news/1-moderna-immatics-jointly-cancer-113125165.html

BioLineRx: Approval of Combo for Collection, Autologous Transplantation in Multiple Myeloma

 APHEXDA is the first innovation in stem cell mobilization for multiple myeloma to be approved in the U.S. in a decade -

One dosage of APHEXDA plus filgrastim enabled a majority of patients to achieve the collection goal of ≥ 6 million hematopoietic stem cells among a contemporary population of multiple myeloma patients -

Management to hold conference call on Tuesday, September 12, 2023 at 8:00 a.m. U.S. EDT -

The Company will host an investor conference call on September 12, 2023 at 8:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer.

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until September 14, 2023; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

https://finance.yahoo.com/news/biolinerx-announces-fda-approval-aphexda-110000569.html

Marker: Complete Response in First Lymphoma Patient Treated with MT-601 after CAR T Relapse

 Marker Therapeutics reports clinical updates in APOLLO trial for the treatment of lymphoma patients who have relapsed after anti-CD19 CAR T cell therapy

Patient with Non-Hodgkin’s Lymphoma who relapsed after anti-CD19 CAR T cell therapy tolerated initial dose level well and achieved complete response after MT-601 treatment

https://www.globenewswire.com/news-release/2023/09/11/2740646/0/en/Marker-Therapeutics-Announces-Complete-Response-in-First-Lymphoma-Patient-Treated-with-MT-601-after-CAR-T-Relapse.html

Bausch + Lomb Announces Launch of Proposed Financing for Acquisition of XIIDRA

 Bausch + Lomb Corporation ("Bausch + Lomb") (NYSE/TSX:BLCO), a subsidiary of Bausch Health Companies Inc. (the "Company") (NYSE/TSX:BHC), announced today that, in connection with the financing of its pending acquisition (the "Acquisition") of XIIDRA® and certain other ophthalmology assets, Bausch + Lomb Escrow Corp. (the "Escrow Issuer"), a wholly owned subsidiary of Bausch + Lomb, launched an offering of $1.4 billion aggregate principal amount of new senior secured notes due 2028 (the "Notes") and that Bausch + Lomb is seeking to enter into an incremental term loan facility ("Term Loan Facility"), which will be secured on a pari passu basis with Bausch + Lomb's existing term loan facility and will either be in the form of an incremental amendment to Bausch + Lomb's existing term loan facility or a separate credit agreement. Bausch + Lomb is expected to borrow $500 million of new term B loans (the "New Term B Loans") under the Term Loan Facility upon the closing of the Acquisition.

The net proceeds of the New Term B Loans and the offering of the Notes are expected to fund the Acquisition, to pay fees and expenses related to the Acquisition, the borrowings of the New Term B Loans and the offering of the Notes and for general corporate purposes, including the repayment of existing debt.

Closing of the Term Loan Facility will be conditioned upon completion of the Acquisition and will occur concurrently with the closing of the Acquisition. Closing of the Notes offering will not be conditioned upon completion of the Acquisition, but if the Acquisition does not occur on or prior to September 30, 2024, the Escrow Issuer will be required to redeem the Notes at such time at a redemption price equal to the principal amount of the Notes plus accrued and unpaid interest.

https://finance.yahoo.com/news/bausch-healths-bausch-lomb-announces-120000540.html

Alnylam amyloidosis drug led to “small” benefits: FDA

 The U.S. FDA said Monday that Alnylam Pharmaceuticals' (ALNY) amyloidosis therapy patisiran led to a "small" clinical benefit in a Phase 3.

https://seekingalpha.com/news/4010608-alnylam-amyloidosis-drug-patisiran-small-benefits-fda

NovaBay, BioStem to Commercialize Amniotic Tissue Allograft

 NovaBay Pharmaceuticals, Inc. (NYSE American: NBY) and BioStem Technologies, Inc. (OTC: BSEM) announce an agreement under which NovaBay has been granted the right to commercialize BioStem Technologies’ Amniotic Tissue Allograft, which is intended for use as a protective covering during the repair of ocular surfaces.

Amniotic Tissue Allograft provides a protective environment or covering for repair of the cornea and conjunctiva, helping ocular surface to return to a healthier state. NovaBay intends to commercialize the prescription-only product as Avenova Allograft to leverage its Avenova eyecare brand and encourage use with other Avenova products. Medically necessary procedures with the Avenova Allograft will be reimbursed through Medicare.

Placentally derived human amniotic membrane is a potent source of pro-healing growth factors and anti-inflammatory cytokines. Amniotic allografts have successfully been used in regenerative medicine for over a century and dehydrated human amniotic membrane continues to be widely used as an ophthalmic covering. Avenova Allograft is the only optic allograft manufactured using BioStem Technologies’ patented six-step BioREtain® process that preserves the natural integrity of the placental tissue. This new NovaBay-branded product will compete in the global ophthalmology amniotic membrane market estimated at $403.6 million in 2022, and is expected to grow at 9.8% per year between 2023-2030.

https://finance.yahoo.com/news/novabay-pharmaceuticals-announces-agreement-biostem-120000360.html

Bristol: Reduced Rate of Lung Function Decline in Progressive Pulmonary Fibrosis Cohort of Phase 2

 

  • Results show 26 weeks of treatment with twice-daily 60 mg dose of BMS-986278 resulted in a 69% relative reduction in the rate of decline in percent predicted forced vital capacity versus placebo
  • Treatment effect was consistent with or without background therapy and BMS-986278 was well tolerated, with rates of adverse events similar to placebo and low discontinuation rates
  • These progressive pulmonary fibrosis findings, along with the previously reported idiopathic pulmonary fibrosis cohort results, support continued development of BMS-986278 in Phase 3 ALOFT program