AL-002

Plus, news about Bavarian Nordic, Nuvectis Pharma, Flashpoint Therapeutics, Sparian Biosciences and TFF Pharmaceuticals: Vitalli Bio axes Daewoong asset: Vitalli, founded by Joe Jimenez’s Aditum Bio , plans to terminate its licensing agreement for an autoimmune disease drug developed by Daewoong Pharmaceutical, according to a regulatory filing . The deal was worth up to $477 million for Daewoong. Vitalli still has the option for two additional candidates from Daewoong, the company said. Jimenez declined to comment, citing “confidentiality with our partners.” — Kyle LaHucik Alector takes out $50M loan: The money from Hercules Capital will help fund two studies: a Phase 3 for latozinemab in frontotemporal dementia, and a Phase 2 for AL002 in early Alzheimer’s disease. Alector will receive $10 million immediately and can get another $15 million at any time before June 30, 2026. The final $25 million will be available at Hercules’ approval. — Max Gelman Bavarian Nordic secures $340M in mpox, smallpox vaccine orders for 2025: The company told investors that the additional mpox orders contributed to its decision to upgrade its financial guidance for this year. Nearly three million doses of the company’s mpox vaccine MVA-BN have been pledged to Africa so far. — Anna Brown Nuvectis Pharma’s stock dives on Phase 1b data: Of 11 evaluable patients with late-line ovarian cancer who took NXP800, a GCN2 kinase activator, only one patient achieved an unconfirmed partial response, the company said . Nuvectis tested multiple dosing regimens, including different amounts and once- or twice-a-day. Nuvectis’ stock $NVCT closed 46% lower on Thursday. — Max Gelman Flashpoint Therapeutics partners with Saudi Arabia, Northwestern University: The biotech is teaming up with the King Abdullah International Medical Research Center in Riyadh in a $50 million effort to establish a new nanomedicine research center, which will receive the money over five years. Flashpoint also said it expanded its IP to include “150 issued patents and patent applications” through a deal with Northwestern. — Max Gelman Sparian Biosciences’ $19.5M NIH grant: The New York biotech got a five-year grant from the National Institute on Drug Abuse to help develop an opiate use disorder drug through Phase 1. It got a similar grant last year for another drug that aims to treat stimulant use disorder. — Kyle LaHucik TFF Pharmaceuticals to wind down: The Fort Worth, TX-based biotech let go all employees and will shut down . It had been working on dry powder formulations for drugs, including for lung transplant rejection, flu and Covid. It had $4.4 million in cash and equivalents at the end of June. — Kyle LaHucik

iStock, Michael Vi AbbVie’s Humira missed Wall Street’s expectations in the third quarter but Skyrizi and Rinvoq’s continuing outperformance demonstrated the overall strength of its immunology franchise. Despite the continued biosimilar erosion on Humira sales, AbbVie exceeded analyst expectations in its third-quarter earnings report on Wednesday, buoyed by the strong growth of its other immunology assets. AbbVie’s revenue jumped 3.8% in Q3 bringing in $14.46 billion, which was 1% ahead of the consensus forecast of $14.3 billion. The company reported adjusted diluted earnings-per-share (EPS) of $3, which also beat Wall Street’s projection of $2.94. AbbVie’s Q3 beat comes despite the steep decline in Humira sales, which cratered 37% year-over-year and dropped to $2.23 billion, compared to $3.55 billion during the same period last year. In an investor call on Wednesday, CCO Jeffrey Stuart attributed the company’s shrinking Humira business to its loss of exclusivity and “biosimilar competition,” particularly in the U.S. Still, company executives were optimistic about its immunology unit on the call, with AbbVie CEO Robert Michael saying that he is “extremely pleased” with the performance of the ex-Humira platform. “AbbVie’s diversified portfolio delivered sales that were $260 million above our expectations, Michael said, noting that “our ex-Humira platform drove this overachievement.” Skyrizi, indicated for plaque psoriasis and psoriatic arthritis and which AbbVie has positioned as a successor to Humira, surged 50.8% in Q3 with $3.2 billion in net revenue—surpassing both the analyst consensus. Rinvoq, an oral JAK inhibitor approved for ulcerative colitis, Crohn’s disease and other immune-mediated diseases, grew 45.3% in the quarter with $1.17 billion in sales. William Blair analyst Myles Minter in an investor note wrote that AbbVie’s Q3 beat “was mainly driven by continued strength of Skyrizi and Rinvoq,” adding that AbbVIe is likely looking at “strong and durable growth pro the coming years thanks to its strong growth platform.” Regarding the biosimilar challenge to Humira, Minter noted that “AbbVie has managed the erosion well,” which in turn will give investors “enough visibility to get comfortable with the strong growth outlook for AbbVie over the near and long term.” Guggenheim Partners analyst Vamil Divan pointed to AbbVie’s cancer products Imbruvica and Venclexta, which “performed better than the Street expected.” Venclexta saw nearly 15% year-over-year growth and brought in $677 million in Q3, while Imbruvica—despite earning $828 million—was hit with an 8.8% decline in sales. Looking at AbbVie’s pipeline, Leerink Partners analyst David Risinger flagged an upcoming readout for emraclidine, a potentially best-in-class next-generation anti-psychotic drug being developed for schizophrenia. Data from two Phase II studies—EMPOWER-1 and EMPOWER-2—are expected by the end of the year . Risinger also called out two “Alzheimer’s wildcards,” ABBV-552 and AL002, both of which are in Phase II.