FDA decision Watch: Regeneron and Roche's autoimmune drugs, Capricor's DMD therapy in spotlight. Published: Nov 02 2026, 05:15 PM IST * FB * TW * Linkdin * Whatsapp * GNFollow Us November brings several closely watched FDA decisions, with Regeneron and its partner Alnylam's therapy for generalized myasthenia gravis and Roche's Gazyva for primary membranous nephropathy in the spotlight this week. * Regeneron and Alnylam's Cemdisiran showed significant improvements in daily functioning and muscle strength in a Phase 3 trial. * Alnylam could receive royalties of up to 15% of worldwide sales of Cemdisiran. * Roche awaits decisions on two drugs this month, including one for breast cancer. The U.S. Food and Drug Administration (FDA) is set to rule on several key drugs in the penultimate month of 2026, with Capricor Therapeutics' (CAPR) Deramiocel among the most closely watched decisions after the regulator extended its deadline by three months. Regeneron Pharmaceuticals (REGN) and its partner Alnylam Pharmaceuticals (ALNY), along with Roche (RHHBY), are also awaiting FDA decisions on their respective autoimmune disease treatments this month, although exact dates have not been disclosed. Regeneron and Alnylam await FDA decision on Cemdisiran. In June, the FDA granted Priority Review to Cemdisiran for generalized myasthenia gravis, an autoimmune disease that causes muscle weakness, with results expected any time this month. The Phase 3 Nimble trial testing the drug showed that patients receiving Cemdisiran experienced a 4.5-point improvement in daily functioning after 24 weeks, compared with 2.2 points for those receiving placebo. About 76.6% of Cemdisiran-treated patients achieved a clinically meaningful improvement of at least three points, compared with 44.1% in the placebo group. The treatment, administered through an injection once every three months, also met its secondary goal of improving muscle strength, with benefits observed by the second week of treatment. Regeneron is developing Cemdisiran under license from Alnylam, which could receive royalties of up to 15% of worldwide sales. Roche eyes two FDA decisions in November. Roche is awaiting FDA's decision on Gazyva for primary membranous nephropathy, a rare autoimmune disease that damages the kidneys and can eventually lead to kidney failure. The regulator granted Priority Review in July. The drug could become the first FDA-approved treatment specifically for the disease. In the Phase 3 MAJESTY trial involving 142 patients, 36.9% of Gazyva-treated patients achieved complete remission after two years, meeting the trial's primary and secondary goals. Separately, the FDA is also set to announce its decision on Roche's experimental breast cancer drug Giredestrant on November 30. The drug is being developed for patients with early-stage, estrogen receptor-positive, HER2-negative breast cancer. Roche sees peak annual sales exceeding CHF3 billion ($3.65 billion). How have RHHBY, ALNY and REGN stocks fared so far in 2026? Retail sentiment for RHHBY on Stocktwits remained 'bearish' over the past 24 hours, while sentiment for REGN remained 'extremely bullish' and 'bullish' for ALNY. Regeneron and Roche shares have gained 19.5% and 17.9% so far this year, respectively, while Alnylam Pharmaceuticals stock has slumped about 59%. Both Roche and Regeneron clocked their biggest monthly gains in October. ALNY shares have gained in just two months in 2026. Also read: Stocktwits Defense Watch: L3Harris, BA Report Record Backlogs, HII Raises FY2026 Shipbuilding Revenue Forecast (Exchange Rate: CHF1 = $1.22) Stay updated with all the latest Business News, including market trends, Share Market News, stock updates, taxation, IPOs, banking, finance, real estate, savings, and investments. Track daily Gold Price changes, updates on DA Hike, and the latest developments on the 8th Pay Commission. Get in-depth analysis, expert opinions, and real-time updates to make informed financial decisions. Download the Asianet News Official App from the Android Play Store and iPhone App Store to stay ahead in business. 0 Comments / 0 New

Regeneron beat Wall Street expectations in its third quarter, with revenue of $5.12 billion against analyst estimates of $4.60 billion. Revenue rose 36.3% year on year, while adjusted earnings per share came in at $20.07, versus an expected $16.25. Operating margin reached 40%, up from 27.3% a year earlier. DUPIXENT, EYLEA HD, and LIBTAYO all hit record sales, and the expanded Sanofi collaboration also helped. Analysts asked about the CIDEB obesity-related programme, the planned launch of cemdisiran, and possible expansion of the Sanofi alliance to oral STAT6 inhibitors. Chief executive officer Leonard Schleifer said injectables dosed quarterly or twice a year may beat daily pills on convenience and efficacy. Regeneron's market value is $93.11 billion. Its shares trade at $928, up from $818.77 before earnings.

Why is Regeneron Stock going up? November 1st, 2026 · by Trefis Team REGNYTD+20.7% SPYYTD+11.4% XLVYTD+20.4% For questions about this article or underlying research, email [email protected]. Regeneron Pharmaceuticals (REGN) stock rose 13.3% on Friday, October 30, 2026, while the S&P 500 fell 1.8%. The advance occurred as Regeneron reported third-quarter 2026 results that topped analyst estimates for both earnings and revenue. By how much did Regeneron beat, and what was behind it? What Did Regeneron Report On October 30? Regeneron surpassed analyst estimates by a wide margin on both the top and bottom lines. The company posted adjusted earnings per share of $20.07 against an analyst estimate of $16.51, alongside revenue of $5.12 billion against a $4.58 billion estimate. Management said revenue grew 36% from a year earlier, mainly because of higher collaboration revenue from Sanofi, along with growth in Libtayo and EYLEA HD. News reports linked the rise to EYLEA HD and to Regeneron's Dupixent profits from Sanofi. Regeneron and Sanofi share the profits from a collaboration that includes Dupixent. Because Regeneron finished repaying a balance of development costs to Sanofi in the second quarter, management said the third quarter marked the first period the company recorded its full share of those profits. That shift was visible in the figures. Regeneron's share of the collaboration profits climbed 77% from a year earlier, an increase management put down mainly to Dupixent sales growth and the finished repayment. In total, collaboration revenue from Sanofi reached an all-time high of $2.7 billion. EYLEA HD, part of Regeneron's retinal franchise, generated U.S. sales of $699 million, up 62% from a year earlier. Even so, combined U.S. sales of EYLEA HD and EYLEA fell 1% over the same period. Did Regeneron Rise On Its Own? Mostly, yes. Every company on Regeneron's Trefis peer list advanced that session, logging gains that ranged from 1.1% for Amgen to 2.2% for Merck. XLV, the health care sector fund, added 0.5%. The wider market fell, and news reports tied that drop to selling in AI stocks after earnings from Amazon and Intel. None of the peers or the sector fund rose by more than 2.2%, so most of Regeneron's gain was its own. Regeneron Stock Closed At Its Highest In A Year No session in the prior 365 days brought Regeneron a rise this large. The stock closed at $927.89, establishing its highest close in the past 365 days and sitting well above its lowest close of $600.66 on June 1, 2026. Over the past twelve months it returned 42.8%, compared with 11.3% for the S&P 500. Much of that climb came in October: from October 1 to October 30 the stock returned 26.3%, while the S&P 500 lost 1.1%. Looking ahead, management expects to record a $1 billion upfront payment from Sanofi as collaboration revenue in the fourth quarter under a recently amended antibody collaboration. The updated deal requires Regeneron and Sanofi to equally split the development and commercialization costs of four next-generation antibodies and share their profits 50/50. The terms for Dupixent stay the same. Regeneron's share of the Sanofi collaboration profits is the figure to watch when the company reports fourth-quarter 2026 results, expected in January 2027. In the third quarter, that share accounted for $2.6 billion of the $2.7 billion in Sanofi collaboration revenue. How To Act On REGN? Not necessarily on Regeneron Pharmaceuticals alone, if your goal is long-term wealth. Wealth is built by owning the companies that keep outperforming, the leaders of their industries, wherever they are. Here are two companies from Regeneron Pharmaceuticals' own industry that have beaten it. Over the five years to October 2026, Amgen stock rose 163% and Exelixis stock rose 223%, while Regeneron Pharmaceuticals stock rose 46%. Finding companies like these takes comparison across industries and sectors, and that is what the Trefis High Quality (HQ) Portfolio does. It holds 30 quality companies in equal weight and, since its inception in September 2020, has returned more than 105%, ahead of a benchmark that combines the S&P 500, S&P Mid-cap and Russell 2000. See how we find the leaders.