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Home » Authors » Lee Landenberger

Articles by Lee Landenberger

Onpattro

Alnylam posts an adcom win but shares slide

Sep. 14, 2023
By Lee Landenberger
A U.S. FDA advisory committee’s backing keeps Alnylam Pharmaceuticals Inc.’s Onpattro (patisiran) on the road to a supplemental approval in treating a rare heart disease, but it couldn’t stop the company stock from sliding. Shares (NASDAQ:ALNY) closed Sept. 14 down 8.8% at $193.06, the day after the Cardiovascular and Renal Drugs Advisory Committee voted 9-3 that patisiran’s benefits outweigh the risks in treating cardiomyopathy of transthyretin-mediated amyloidosis.
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Ignition: Rocket Pharma offering and phase II launch the stock

Sep. 13, 2023
By Lee Landenberger
The combination of new U.S. FDA phase II study guidance and a $175 million underwritten public offering sent gene therapy developer Rocket Pharmaceuticals Inc.’s stock soaring on Sept 13. Shares (NASADQ:RCKT) closed 38.8% upward to $21.23 each on Sept. 13.
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Blood vessels

Humacyte’s phase II/III tissue graft data prompt talk of a BLA

Sep. 12, 2023
By Lee Landenberger
Regenerative tissue developer Humacyte Inc. has posted positive top-line phase II/III results for its Human Acellular Vessel, a tissue-engineered graft consisting entirely of decellularized extracellular matrix, for vascular trauma repair. The data showed higher rates of patency, a measure of the lack of vascular obstruction, when compared to synthetic graft benchmarks.
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Aphexda

Biolinerx’s stem cell mobilizer approved for MM patients

Sep. 11, 2023
By Lee Landenberger
With the U.S. FDA’s approval of Biolinerx Ltd.’s stem cell mobilization agent Aphexda (motixafortide) for treating multiple myeloma (MM) patients, the company is prepping for a launch in the next two or three weeks.
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Twice as nice: With Alexion, Verge cuts another big AI deal

Sep. 8, 2023
By Lee Landenberger
Verge Genomics Inc. has entered a second big AI deal with a large drug company. Privately held Verge will receive up to $42 million, including up-front, equity and near-term payments from Alexion, Astrazeneca Rare Disease, to identify multiple targets for rare neurodegenerative and neuromuscular diseases. The deal could top out at $840 million. There also is potential for downstream royalties.
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Scientist, microscope and dropper

In a cancer development deal with Seagen, Nurix could bring in up to $3.4B

Sep. 7, 2023
By Lee Landenberger
In a mammoth deal with a potentially huge payoff, Nurix Therapeutics Inc. and Seagen Inc. will collaborate to develop what they call a new class of medicines, Degrader-Antibody Conjugates, to create drugs with new mechanisms of action for treating cancer.
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Ultomiris

AZ gets CRL asking for REMS changes to rare disease sBLA

Sep. 6, 2023
By Lee Landenberger
While the U.S. FDA didn’t ask for more study data or have safety or efficacy concerns, it does want modifications to Alexion, Astrazeneca Rare Disease’s sBLA for Ultomiris (ravulizumab-cwvz) to treat adults with the rare central nervous system disease neuromyelitis optica spectrum disorder. The agency has issued a complete response letter (CRL) requesting changes to Ultomiris’ Risk Evaluation and Mitigation Strategy (REMS) to better validate patients’ meningococcal vaccination status or prophylactic administration of antibiotics before being treated.
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Digital handshake

Amgen-Horizon deal is back on as FTC steps back

Sep. 1, 2023
By Lee Landenberger
The U.S. FTC’s antitrust challenge to Amgen Inc.’s $27.8 billion acquisition of Horizon Therapeutics plc has been resolved. Amgen agreed to do what it said it would do all along: not bundle pharmacy benefit manager rebates on high volume blockbuster drugs Tepezza and Krystexxa.
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Hands holding gears

Acer stabilizes with Zevra merger and Relief deal

Aug. 31, 2023
By Lee Landenberger
Zevra Therapeutics Inc. will acquire Acer Therapeutics Inc. in a $91 million deal that combines two companies with expertise in rare diseases. Acer has struggled since its hot flash drug, ACER-801 (osanetant), failed to hit statistical significance in a phase IIa proof-of-concept study in March 2023. The stumble came amidst the launch of Acer’s Olpruva, a sodium phenylbutyrate for oral suspension therapy approved by the U.S. FDA in late December 2022 for treating urea cycle disorders. The day before the Zevra merger was announced, Acer reacquired the worldwide development, commercialization and economic rights to Olpruva from its development partner, Relief Therapeutics Inc.
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Woman taking Amsler grid eye exam

Outlook says CRL for wet AMD is a surprise

Aug. 30, 2023
By Lee Landenberger
After hitting the safety and efficacy endpoints in a pivotal study of wet age-related macular degeneration (AMD), Outlook Therapeutics Inc.’s CEO said he had not expected to receive a complete response letter (CRL) from the U.S. FDA. The BLA for ONS-5010 (bevacizumab-vikg) now is on hold, the company said, because the agency said chemistry, manufacturing, and controls management problems were getting in the way, along with “open observations from pre-approval manufacturing inspections, and a lack of substantial evidence.”
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