Needham Sees Market Potential For Arcellx Multiple Myeloma Candidate, Sees 50% Upside In Stock

 

• Needham initiated coverage on Arcellx Inc 
  ACLX+0.59%+ Free Alerts
   with a Buy rating and a price target of $31.
• Arcellx's lead program and main value driver is CART-ddBCMA, an autologous CAR-T therapy for relapsed or refractory (r/r) multiple myeloma (MM). 
• With two CAR-Ts already on the market - Bristol Myers Squibb Co's 
  BMY-0.05%+ Free Alerts
   Abecma and Johnson & Johnson's 
  JNJ-0.56%+ Free Alerts
   Carvykti, Arcellx is a fast follower. 
• The analyst says that early data for CART-ddBCMA supports an efficacy profile in line with the market leader (Carvykti).
• While the MM market is crowded, Needham analyst believes CAR-Ts have demonstrated the best activity and that the incumbents are insufficient, given market needs. 
• A physician survey identified access as a key issue, finding that only 35% of CAR-T-eligible patients receive treatment. 
• Assuming 20% market penetration, CART-ddBCMA sales are estimated to reach $3 billion in 2033. 
• Broader platform play (ARC-SparX) could also add a potential upside. A clinical update is expected in 4Q:22, with a pivotal study in 2023.

https://www.benzinga.com/general/biotech/22/10/29444756/analyst-sees-market-potential-for-arcellx-multiple-myeloma-candidate-sees-50-upside-in-stock

PTC in Financing Collaboration with Blackstone with up to $1 B

 Blackstone investment accelerates innovative product pipeline -

- PTC will leverage Blackstone's network and life sciences expertise to broaden business development effort -
- PTC to receive $350 million in cash at close -

https://finance.yahoo.com/news/ptc-therapeutics-announces-strategic-financing-200100141.html

Ferring halts all shipments of flagship fertility drug Menopur after third-party manufacturing pivot

 Women worldwide who count on Ferring Pharmaceuticals' flagship fertility drug may be out of luck for the foreseeable future.

That’s because the Swiss company announced a pause on global shipments of the injectable med, known as Menopur, citing “changes made in the manufacturing process” for Menopur's ingredients “by a third-party supplier,” a Ferring spokesperson told Fierce Pharma.

The move was first reported by Business Insider, which quoted a memo Ferring’s chief science officer, Elizabeth Garner, M.D., reportedly sent to healthcare providers Wednesday that informed them of the supply halt.

“We are currently reviewing this situation and will provide updates as appropriate,” the company’s spokesperson said via email. Ferring has alerted the FDA and other global regulators to the issue and is working to mitigate any disruptions to supply, he added.

As of Thursday, the therapy, known generically as injectable menotropins, had not turned up on the FDA’s online drug shortage database.

While Ferring is temporarily pausing shipments of its product, information reviewed to date suggest “the safety and efficacy of the product remains unaltered,” the company’s spokesperson explained. “Ferring is not aware of any evidence indicating that the changes in the manufacturing process pose any risks to patients.”

The move covers all shipments of Menopur, which triggers the release of eggs from the ovaries of women who are not ovulating. A spokesperson from the company’s Singapore division told Business Insider they could not comment on the potential timing of the product's return to the market. Women undergoing in vitro fertilization need daily doses of Menopur for up to 20 days, according to the drug’s label (PDF).

For all of 2022, Menopur brought home sales of around 753 million euros, Ferring said in its annual report published (PDF) in April. 

On the whole, Ferring posted total 2021 revenues of  2.16 billion euros, rising 14% over the previous year at constant exchange rates. 

The company is primarily focused on reproductive medicine and maternal health, and, with Menopur at the fore, Ferring has managed to grow sales in that segment of its business by 27% over the last two years, the company said in a release last spring.

https://www.fiercepharma.com/manufacturing/ferring-halts-all-shipments-its-flagship-fertility-drug-menopur-after-third-party

Gilead reports lower 3rd-quarter profit as COVID drug sales slow

 

Gilead Sciences Inc on Thursday said third-quarter profit fell due to lower sales of its COVID-19 antiviral drug and acquisition expenses, but demand for HIV and cancer drugs remained strong and the company increased its outlook for full-year revenue and earnings.

Quarterly revenue fell 5% to $7 billion, but was still ahead of the average Wall Street estimate of $6.12 billion, according to Refinitiv data.

Sales of COVID treatment remdesivir, sold under the brand name Veklury, fell 52% from a year earlier to $925 million. But that was still well ahead of analysts' estimates of $328 million.

The U.S. biotech company said adjusted quarterly profit fell 28% to $1.90 per share, which also beat Wall Street expectations of $1.43 per share. Net income fell to $1.42 per share from $2.05 per share.

"What you've seen is an over performance ... both on Veklury, but also, I think, very importantly on our base business," Gilead Chief Executive Daniel O'Day told Reuters.

The CEO said Gilead expects demand for Veklury to continue to slow, but "like the rest of the world, we've had to struggle to look into the crystal ball and know exactly where the pandemic can go."

Gilead's HIV product sales increased 7% to $4.5 billion in the quarter, driven by higher prices and demand.

Sales of cancer drug Trodelvy rose 78% to $180 million, while sales of Gilead's cancer cell therapies increased 79% to $398 million.

For the full year, Gilead said it now expects product sales of $25.9 billion to $26.2 billion, up from a previous forecast of $24.5 billion to $25 billion.

The company also raised its outlook for 2022 adjusted earnings to between $3.35 and $3.55 per share from a previous range of $2.90 to $3.30.

https://www.marketscreener.com/quote/stock/GILEAD-SCIENCES-INC-4876/news/Gilead-reports-lower-3rd-quarter-profit-as-COVID-drug-sales-slow-42112158/