Mizuho Medy Co., Ltd.

iStock, hapabapa While Amgen’s third-quarter financial results on Wednesday were “somewhat uneventful,” investors continue to be focused on the highly anticipated MariTide Phase II results slated for late 2024, according to BMO Capital Markets analyst Evan Seigerman. Amgen released its third-quarter earnings report on Wednesday, revealing an overall solid performance in Q3 despite misses by some of its key products. The company’s revenues in the quarter came in at $8.5 billion, representing 23% year-over-year growth. Amgen’s total revenues were broadly in line—if not slightly behind—the consensus estimate of $8.51 billion. Non-GAAP earnings-per-share (EPS) was $5.58, which beat the analyst forecasted figure of $5.13. Amgen CEO Robert Bradway in an investor call credited its strong Q3 performance on 10 products, which delivered “double-digit or better sales growth.” Among its key growth drivers was the acute lymphoblastic leukemia therapy Blincyto, which surged 49% year-over-year to bring in $327 million in the quarter, and beating the consensus estimate by 19%. Meanwhile, Repatha saw a 40% jump in sales compared to the same period last year. The hyperlipidemia medicine brought in $567 million in Q3, coming 6% ahead of analyst expectations. The oral non-small cell lung cancer pill Lumakras also had strong growth in the quarter, jumping 88% year-over-year to hit global sales of $98 million. Lumakras beat the Wall Street consensus, surpassing projections by 18%. By contrast, Amgen’s top-selling assets Tepezza and Prolia had a largely disappointing Q3, with the thyroid eye disease therapy generating $488 million in the quarter—missing the consensus expectation by 4%-- while the osteoporosis injection secured nearly $1.05 billion, 6% lower than analysts’ forecast. Sales of the autoimmune medication Enbrel dropped 20% in the quarter with revenues of $825 million, which also fell 10% short of the consensus. BMO Capital Markets analyst Evan Seigerman in an investor note called Wednesday’s results “somewhat uneventful,” marked by “limited details” for the Amgen’s highly anticipated obesity candidate MariTide. Executives on the investor call only revealed that the MariTide Phase II study is “progressing well” and that they are currently planning to “launch a broad Phase III program” for the candidate, targeting obesity and related conditions as well as type 2 diabetes. Data from MariTide’s Phase II study are expected “later this year,” according to Bradway. After the call, Mizuho analyst Salim Syed in an investor note said that there was “not much new learned” about the the company’s obesity portfolio, pointing out that Amgen provided only “incremental points” regarding its development plans in this space. “Management again alluded to a ‘differentiated profile,’ but no additional [details] of substance were really provided,” even in the Q&A portion of the call, according to Syed. For Jefferies analyst Michael Yee, a lot is riding on Amgen’s impending MariTide readout. Yee called the company’s Q3 results “ho-hum” but noted that investors are willing to “look past this … if the obesity data is good.” The focus for MariTide, according to Yee, is on its “long-term blockbuster potential.” However, “if data is messy, investors will be more frustrated,” given that Amgen’s business will be “under some pressure” in 2025, including the impending entry of Prolia biosimilars, Yee wrote.

Plus, news about Verastem Oncology, Bright Minds Biosciences and Telix Pharmaceuticals: Aura Biosciences unveils early bladder cancer data: The Boston biotech shared that its light-activated drug led to four complete responses in five patients with low-grade non-muscle invasive bladder cancer. In high-grade NMIBC, the drug did not lead to complete responses, but two of three patients saw “visual tumor shrinkage” via a cystoscopy. Last month, Aura unveiled results in a rare eye cancer, the lead indication for its experimental drug that’s known as bel-sar for short. Aura’s shares $AURA jumped about 10% Friday morning. — Lei Lei Wu Poseida scores $15M milestone payment from Roche: Poseida received the milestone after Roche nominated a new dual CAR-T therapy per a 2022 deal. The therapy targets antigens expressed in hematologic malignancies, including multiple myeloma. The companies now have three programs in development, and their lead program is a CAR-T therapy targeting BCMA in the third-line multiple myeloma setting. — Katherine Lewin Verastem Oncology’s stock falls despite positive mid-stage data: In a Phase 2 trial, ovarian cancer patients taking avutometinib and defactinib saw median progression-free survival of 12.9 months, and those with the KRAS mutation had 22 months. The company said it plans to complete its NDA submission this month. Verastem’s stock $VSTM fell about 20% in after-hours trading on Thursday, with Mizuho analysts attributing the stock’s weakness to Verastem’s decision to first seek approval for patients with a KRAS mutation, and not those with wild-type KRAS. — Katherine Lewin Bright Minds Biosciences’ $35M private placement : The funds are set to go toward R&D expenses and general working capital. The company’s stock $DRUG soared about 70% on Friday following the announcement. Earlier this week, Bright Minds announced positive preclinical data for BMB-201, which showed that it outperformed morphine in efficacy. The company now plans to move the drug into clinical trials. — Katherine Lewin Telix Pharmaceuticals files for NASDAQ inclusion: The Australian radiopharma company said listing on the NASDAQ will increase interest from both US and global investors. Last month, Telix paid $230 million upfront to buy radioisotope manufacturer RLS Radiopharmacies. — Katherine Lewin

iStock, jetcityimage Wave Life Sciences in a Tuesday filing with the SEC said Takeda has elected to terminate its option to continue work on Wave’s WVE-003 clinical-stage Huntington’s disease program—a potential $5 billion commercial opportunity, according to the biotech. Japanese pharma Takeda will no longer be working with Wave Life Sciences on the investigational antisense oligonucleotide WVE-003 for the treatment of Huntington’s disease, according to an SEC document filed by the Massachusetts-based biotech on Tuesday. Wave in its filing did not detail why Takeda pulled out of its partnership, noting only that the pharma no longer intends to exercise “and therefore elected to terminate its option” to take the candidate forward. The biotech will now have full responsibility over WVE-003 and will be able to develop the investigational therapy “independently or with other partners.” Because the Huntington’s program was the only remaining active collaboration between Takeda and Wave, the standing agreement between the two companies—which was inked in February 2018 —is “expired with immediate effect,” per the SEC filing. Wave has received around $260 million from Takeda under this agreement. Under the original 2018 agreement, Takeda made a $110 million upfront payment and a $60 million equity investment for the option to co-develop and co-commercialize various neuro programs, including Huntington’s disease, amyotrophic lateral sclerosis and frontotemporal dementia. Takeda took the first step away from Wave in 2021, when it paid $22.5 million to abandon the discovery research part of the deal and instead focus on clinical-stage candidates. Takeda’s decision to withdraw from the Huntington’s partnership is unexpected, particularly as WVE-003 just recently cleared its Phase Ib/IIa study . Wave in June 2023 announced that the antisense oligonucleotide significantly and selectively lowered levels of the mutant huntingtin protein by 46% at 24 weeks, or around eight weeks after the final dose. The mid-stage study found that the reduction in mutant huntingtin was also tied with slower atrophy in the caudate region of the brain, a known imaging biomarker of clinical outcomes in Huntington’s disease. WVE-003 also slowed the decline of motor function in patients, though the study was not powered to detect significant effects on clinical outcomes, Wave said at the time. “WVE-003 alone represents a potential $5 billion commercial opportunity, with potential to expand to $10 billion with programs targeting other single nucleotide polymorphisms (SNPs), and Wave’s recently completed SELECT-HD clinical trial has generated significant interest from prospective partners,” the company said in Tuesday’s SEC filing, noting that it expects “feedback from the regulators on a potential pathway to accelerated approval for WVE-003 by the end of 2024.” For Wave, Takeda’s decision comes as the biotech continues to gain ground in its other pipeline programs. On Wednesday, Wave reported that it successfully delivered the “first-ever clinical demonstration of RNA editing in humans.” Proof-of-mechanism data showed that its investigational oligonucleotide WVE-006 restored expression levels of the M-AAT protein in alpha-1 antitrypsin deficiency (AATD) patients with genotypes that would have otherwise prevented them from producing this protein. Designed to be subcutaneously administered, WVE-006 is an RNA editing oligonucleotide that works by changing the A residue on its target RNA to an I residue. It is being developed to address AATD-related lung or liver diseases, or both. Wave last month also announced that its exon-skipping oligonucleotide WVE-N531 improved dystrophin expression in patients with Duchenne muscular dystrophy. Mizuho analyst Salim Syed at the time said that WVE-N531’s performance “exceeded the bar for efficacy” with a “clean” safety profile. In its SEC filing on Tuesday, Wave maintained that losing Takeda as a development partner will not affect its cash runway. The biotech expects its current cash and cash equivalents to be enough to support it into 2027. Wave is scheduled to hold a virtual research day on October 30 .